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

Model Number	5386
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturer report number: 2017865-2023-50404, 2017865-2023-50405, 2017865-2023-50406.During a device replacement procedure for normal elective replacement indicator (eri), the right atrial (ra) and right ventricular (rv) leads were capped and replaced.The ra lead was replaced due to noise observed and the rv lead was replaced due to probe protrusion.Additionally, it was observed that blood had leaked into the device header of the old device and that blood was observed in the new device header.The new device was explanted and replaced during the procedure to resolve the event.The patient was stable following the replacement of the leads and device.
Additional Manufacturer Narrative
The reported events of contamination of device ingredient or reagent was not confirmed.The device was in backup mode upon receipt which occurred post-explant consistent with exposure to cold temperature.Visual inspection of the header found the ventricular setscrew stripped off by end-user due to inserting the wrench tool an angle to the setscrew stripping the setscrew inset, additionally, no contamination or foreign material found that could contribute to the reported event.Electrical analysis performed after replacing damaged setscrew indicated normal functionality.Results of sensitivity analysis performed at most sensitivity level was within normal range.Longevity analysis was performed, and the device exceeded projected longevity indicating normal battery 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17987866
• Report Number: 2017865-2023-50402
• Device Sequence Number: 8199083
• Product Code: DXY
• UDI-Device Identifier: 05414734006903
• UDI-Public: 05414734006903
• 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: 2009
• 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): 12/04/2023

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: 10/31/2010
• Device Model Number: 5386
• Device Lot Number: 2905158
• 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: 10/08/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2009
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENDURITY¿ CORE DR, JPD; ISOFLEX S LEAD; TENDRIL ST
• Patient Sex: Unknown