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

Model Number	5386
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a clinic follow-up, the low voltage output pacing on the device was lower than the programming minimum voltage.The device was reprogramming as an interim resolution as the device is anticipated to be explanted due to normal elective replacement indicator.The patient was stable and will continue to be monitored.
Event or Problem Description
Additional information was received stating the device was explanted and replaced due to normal elective replacement indicator.
Additional Manufacturer Narrative
The reported event of pacing problem was not confirmed.The device was received at elective replacement level which occurred post-explant reaching end of service during the analysis.Review of the device image indicates auto-capture was enabled and the device was in high output mode at times consistent with the false replacement alert observed in the field.Electrical tests performed, after replacing the original battery indicates normal functionality, and output verification found normal pacing parameters.Additional results not related to the reported event found the pacer did not meet projected longevity from elective replacement to end of service level, caused by unknown source, indicating premature depletion.

• Brand Name: IDENTITY ADX XL DR
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12447194
• Report Number: 2017865-2021-30012
• Device Sequence Number: 3382900
• Product Code: DXY
• UDI-Device Identifier: 05414734507011
• UDI-Public: 05414734507011
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2021

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: Health Professional
• Device Expiration Date: 11/30/2009
• Device Model Number: 5386
• Device Catalogue Number: EX1151
• Device Lot Number: 2958169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 08/26/2021; 12/16/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 09/24/2021; 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2008
• 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