MAUDE Adverse Event Report: ABBOTT ALLURE QUADRA RF CRT-P; NO MATCH

Model Number	PM3242
Medical Device Problem Code	Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient passed away due to an unknown cause.Upon interrogation, the device was observed to be in backup (bvvi) mode.Further information was requested, but not yet available.
Additional Manufacturer Narrative
The reported event of device in backup mode was confirmed.The pacemaker was received in backup mode with the battery voltage at elective replacement indicator (eri).Analysis of the device image revealed that device went into backup mode due to a reset error which is consistent with an integrated circuit (ic) anomaly.The device was restored by reloading product code.Electrical and mechanical analysis was performed, and indicated normal device functionality in bipolar mode.Visual inspection shows external and internal damage consistent with force applied at or after explant that resulted in failed unipolar measurements during analysis.A device history review (dhr) was performed to ensure that each manufacturing and inspection operation was performed.The product passed all quality control tests prior to its distribution.The implant duration exceeds the projected longevity based on average monthly current, indicating normal battery depletion.

• Brand Name: ALLURE QUADRA RF CRT-P
• Common Device Name: NO MATCH
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17818159
• Report Number: 2017865-2023-46444
• Device Sequence Number: 11372701
• Product Code: NIK
• UDI-Device Identifier: 05414734507912
• UDI-Public: 05414734507912
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: PM3242
• Device Lot Number: A000004781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown