MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ENDURITY SR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	PM1160
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned without identified device or use problem.A malfunction based on analysis was found.As received, the device output and telemetry communication were normal.Visual inspection of the header attachment area detected a bonding anomaly.The device was tested for a hermeticity breach which was not observed.The device was cut open to enable further testing and battery was found in normal range.The hybrid circuitry was tested, and the results indicated normal current drain.A manufacturing anomaly may have occurred, which resulted in the header bonding anomaly.
Event or Problem Description
This report is to advise of an event observed during analysis.

• Brand Name: ENDURITY SR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 12555561
• Report Number: 2017865-2021-32271
• Device Sequence Number: 19891609
• Product Code: NVZ
• UDI-Device Identifier: 05414734507042
• UDI-Public: 05414734507042
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2018
• Device Model Number: PM1160
• Device Catalogue Number: PM1160
• Device Lot Number: A000029537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1