MAUDE Adverse Event Report: ABBOTT 5366, INTEGRITY DR, AB 20 73 559; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5366
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During device replacement, there was difficulty removing the atrial lead from the header of the device.The atrial lead was capped and the device was explanted and replaced to resolve the event.The patient was stable following the procedure and there were no adverse consequences.
Additional Manufacturer Narrative
The complaint of removal difficulty was not confirmed.The device was received in back-up mode, without the header.The device image indicated backup operation was caused by multi-bite memory corruption.Actions have been taken to prevent reoccurrence.Analysis performed including electrical testing indicated the device exhibited normal characteristics.The device battery voltage is at eri level and the device measurements were normal throughout the entire tests.A longevity assessment was performed, and the device exceeded the projected longevity, and the battery level is eri.The battery depletion observed is considered normal.

• Brand Name: 5366, INTEGRITY DR, AB 20 73 559
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10376731
• Report Number: 2017865-2020-10697
• Device Sequence Number: 16763267
• Product Code: DXY
• UDI-Device Identifier: 05414734006866
• UDI-Public: 05414734006866
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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: Health Professional
• Device Expiration Date: 05/31/2005
• Device Model Number: 5366
• Device Catalogue Number: 5366
• Device Lot Number: 3016909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1