MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) IDENTITY ADX XL DR; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number	5386
Medical Device Problem Code	Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in clinic for routine follow-up.Upon interrogation, it was found that the pacemaker was inappropriately in back-up operation.Due to low battery, the pacemaker was explanted and replaced.The patient was stable.
Additional Manufacturer Narrative
The reported event of backup was confirmed.As received the device battery was depleted to end of life (eol) level.Final analysis found the device exceeded the projected longevity and is considered normal depletion.No anomalies were found.

• Brand Name: IDENTITY ADX XL DR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17259660
• Report Number: 2017865-2023-25038
• Device Sequence Number: 18113381
• Product Code: DXY
• UDI-Device Identifier: 05414734006903
• UDI-Public: 05414734006903
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023

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: 10/31/2012
• Device Model Number: 5386
• Device Catalogue Number: 5386
• Device Lot Number: 3380483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2023
• 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: 06/14/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TENDRIL; TENDRIL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male