Standard Operating Procedure

Postmarket Surveillance of NURA-Link Leadless Version #: Effective Date: Page 1 of 5

Pacemaker 1.0 03/24/2024

Revision History

Version No. Effective Date Description

1.0 03/24/2024 First version of the document.

Approved By: Date:

Barathkumar Manoharan, Director of R&D 03/24/2024

____________________________________ ____________________

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1. Introduction

1.1 Purpose

This SOP serves as a comprehensive guide for conducting post-market surveillance of the
NURALink Leadless Pacemaker, an innovative cardiac device aimed at providing pacing therapy to patients
with various cardiac conditions. The primary objective is to continually monitor the safety and
effectiveness of the device following its commercial release, ensuring that any potential issues are
identified promptly and appropriate actions are taken to mitigate risks.

1.2 Background

The NURALink Leadless Pacemaker obtained PMA approval based on robust clinical data from the
Leadless II study, comprising two phases. Phase 1, involving 526 subjects, focused on evaluating the safety
and effectiveness of the device. Phase 2, with 200 subjects, validated modifications made to the device.
These studies laid the foundation for the device's regulatory approval and subsequent commercialization.

2. Data Sources

2.1 Specific Data Sources

Adverse Event Reporting:

To facilitate comprehensive adverse event reporting, standardized forms will be made accessible
through various channels, including the manufacturer's website, healthcare provider offices, and
traditional mail services. These forms will capture essential information such as patient demographics,
detailed descriptions of adverse events, device information, actions taken, and relevant medical records.
Additionally, a dedicated toll-free number will be established to facilitate verbal reporting for enhanced
accessibility.

Device Registries:

Establishing a secure, web-based device registry specifically for the NURALink Leadless Pacemaker
will enable the collection of longitudinal data on patient outcomes and device performance. Patients
implanted with the device will be actively encouraged to enroll in the registry, either through direct mail
communication or during routine follow-up appointments. Data collection will include electronic patient-
reported outcome (ePRO) questionnaires and physician-reported data, covering aspects such as quality
of life, device performance metrics, and any reported complications or adverse events.

Literature Reviews:

Regular literature reviews will be conducted by a dedicated team, systematically searching

medical databases for relevant publications related to the NURALink Leadless Pacemaker and related
topics. This proactive approach will enable the identification of any emerging safety or effectiveness

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concerns reported in the scientific literature, ensuring that the post-market surveillance efforts remain
comprehensive and up-to-date.

Customer Complaints:

A robust system will be established for receiving, documenting, and investigating customer
complaints related to the NURALink Leadless Pacemaker. This system may include dedicated email
addresses, phone lines, or online complaint forms to facilitate efficient communication. All complaints will
be thoroughly investigated to determine their root causes, and appropriate corrective actions will be
taken accordingly, such as issuing device recalls, providing technical support to healthcare providers, or
updating device labeling.

3. Data Collection and Analysis

A dedicated team will be responsible for overseeing the collection, processing, and analysis of
data from all relevant sources outlined above. Data will be meticulously collected in a standardized format
to ensure consistency and accuracy, utilizing a secure electronic database for storage. Rigorous statistical
analyses will be conducted to identify any notable trends or patterns in adverse events, device
performance metrics, or patient outcomes.

4. Reporting

Periodic reports summarizing the findings of the post-market surveillance activities will be
generated at predefined intervals, typically annually, and submitted to regulatory authorities such as the
US Food and Drug Administration (FDA). These reports will provide a comprehensive overview of the
number and types of adverse events reported, trends in device performance, emerging safety concerns,
and any relevant effectiveness data obtained from the device registry. Additionally, public reports
summarizing key findings may be prepared and made available on the manufacturer's website to enhance
transparency and public awareness.

5. Risk Management

A proactive approach to risk management will be adopted, with continuous monitoring of

surveillance data to identify potential risks associated with the NURALink Leadless Pacemaker. Any new
or previously unidentified risks will be promptly assessed, and appropriate corrective actions will be
implemented in collaboration with regulatory authorities and other stakeholders. These actions may
include modifications to the device design, updates to labeling or instructions for use, issuance of patient
safety notifications, or other risk mitigation strategies as deemed necessary.

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6. Communication

Effective communication is essential for ensuring that relevant stakeholders are kept informed of post-
market surveillance activities and any pertinent safety or effectiveness concerns. Open lines of
communication will be maintained with healthcare providers, patients, and regulatory authorities through
various channels.

With Healthcare Providers:

Regular communication channels will be established to disseminate important safety information,

such as safety notices or urgent hazard bulletins. Educational workshops or webinars may also be
conducted to update healthcare providers on the latest post-market surveillance findings and best
practices for implanting and managing patients with the NURALink Leadless Pacemaker.

With Patients:

To keep patients informed and engaged, a patient registry newsletter may be published
periodically, providing updates on the device's performance and safety profile. Additionally, a dedicated
patient hotline or email address will be established to address any inquiries or concerns related to the
NURALink Leadless Pacemaker, ensuring that patient feedback is promptly addressed and considered.

With Regulatory Authorities:

Prompt and transparent communication will be maintained with regulatory authorities regarding
any serious adverse events, device malfunctions, or emerging trends identified through post-market
surveillance activities. Regulatory authorities will be promptly notified of any corrective actions taken by
the manufacturer in response to identified risks or safety concerns, facilitating a collaborative approach
to ensuring patient safety and device effectiveness.

7. Training

Comprehensive training programs will be provided to personnel involved in post-market

surveillance activities, including data collection, analysis, reporting, and risk management. These training
programs will cover essential topics such as regulatory requirements for post-market surveillance, data
collection and analysis procedures, risk management principles, and effective communication strategies
with healthcare providers and patients. Initial training will be supplemented by ongoing education and
skill development initiatives to ensure that personnel remain updated on relevant guidelines and best
practices.

8. Recordkeeping

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Strict recordkeeping protocols will be adhered to, ensuring that all documentation related to post-
market surveillance activities is accurately maintained and organized. This includes but is not limited to
adverse event reports, device registry data, literature review summaries, customer complaints, post-
market surveillance reports, risk management documentation, and communication records with
healthcare providers, patients, and regulatory authorities. These records will be stored securely in
accordance with regulatory requirements and the manufacturer's quality management system,
facilitating traceability and accountability.

9. Audit

Regular audits of the post-market surveillance program will be conducted to assess compliance
with this SOP and relevant regulatory requirements. These audits may be performed internally by
designated personnel or by external auditors appointed by regulatory authorities. The audits will evaluate
the effectiveness of the surveillance program, identify any areas for improvement, and ensure that
corrective actions are promptly implemented to address any deficiencies. By maintaining a robust audit
process, the manufacturer can uphold the highest standards of quality and safety in post-market
surveillance activities.

10. References

This SOP adheres to the following standards:

- ISO 14971: Medical devices - Application of risk management to medical devices: This standard provides
guidance on the application of risk management principles to medical devices, ensuring that potential
risks associated with the device are identified, evaluated, and mitigated throughout its lifecycle.

- ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes: This
standard specifies requirements for a quality management system specifically tailored to the medical
device industry, ensuring that manufacturers establish and maintain processes that comply with
regulatory requirements and consistently deliver safe and effective products.

These standards serve as foundational frameworks for the development and implementation of the post-
market surveillance program, ensuring alignment with industry best practices and regulatory
expectations.

11. Revision History

This SOP will undergo periodic review and updates to reflect changes in regulatory requirements,
post-market surveillance data, and device labeling. By maintaining an up-to-date revision history, the
manufacturer can ensure that the SOP remains current and relevant, incorporating new insights and
lessons learned from ongoing surveillance.