MAUDE Adverse Event Report: ABBOTT IDENTITY XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5376
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested but not received.The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During an in clinic follow-up, the device lost communication while being programmed to atrial and ventricular pacing only.Additional attempts to interrogate the device were unsuccessful.The device was explanted and replaced to resolve the event.The patient was in stable condition.
Additional Manufacturer Narrative
The field complaint of interrogation and telemetry anomaly was not confirmed.The device was received in backup mode with battery voltage at end of life (eol) level reached after exceeding projected longevity.The device was attached to a new battery and after reloading the product code, the pacemaker was tested under nominal settings without any anomaly.Additionally, a telemetry test revealed no issues and the device maintained communication with the programmer normally.Total projected longevity based on field settings is 8.06 years.The implant duration was 16.78 years which exceeded the projected longevity and it is considered normal battery depletion.

• Brand Name: IDENTITY XL DR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 9481770
• Report Number: 2017865-2019-18036
• Device Sequence Number: 16240286
• Product Code: DXY
• UDI-Device Identifier: 05414734006880
• UDI-Public: 05414734006880
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2020

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: 05/31/2004
• Device Model Number: 5376
• Device Catalogue Number: 5376
• Device Lot Number: 0002301266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 12/30/2019; 04/13/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 12/30/2019; 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention