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

Model Number	5286
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device could not be interrogated.Premature battery depletion was suspected.The device was explanted and replaced to resolve the event.The patient was stable and there were no adverse consequences.
Additional Manufacturer Narrative
Reported event premature discharge, battery impedance problem, and failure to interrogate were not confirmed.The device was at elective replacement indicator (eri) level upon receipt.Analysis of device image indicated battery impedance was within normal range of operation, device operated at high pacing output settings, and auto-capture was enabled during implant period.When automatic settings are programmed, such as auto-capture, the device would adjust itself to accommodate the patient¿s needs for pacing and thus affects the estimated longevity of the device.Further analysis found no anomaly with the device able to be interrogated successfully though inductive communication.Longevity assessment was performed, and implant duration exceeds total projected longevity indicating normal battery depletion.

• Brand Name: IDENTITY ADX XL
• Common Device Name: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• 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: 17173904
• Report Number: 2017865-2023-23808
• Device Sequence Number: 5754354
• Product Code: DXY
• UDI-Device Identifier: 05414734006828
• UDI-Public: 05414734006828
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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: 02/28/2013
• Device Model Number: 5286
• Device Catalogue Number: 5286
• Device Lot Number: 3462039
• 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: 05/26/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2011
• 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
• Patient Sex: Unknown