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

Model Number	5386
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient presented with over-sensing resulting in inappropriate automatic mode switch.This was alleged to be due to insulation breach on the right atrial competitor lead.No intervention was reported, and the patient was stable throughout.
Event or Problem Description
New information received notes that the device was explanted on (b)(6) 2024.The patient was stable throughout.
Additional Manufacturer Narrative
The reported events of over-sensing, and pacing problem were not confirmed.The device was received with cautery marks on the can.The device reached elective replacement indicator (eri) level during the analysis.Electrical and mechanical analysis performed indicated normal functionality.Sensitivity test performed at most sensitive settings found normal results, and output signal verification measured all pacing parameters within normal range.Additionally, visual inspection of the header and connectors found no contamination or foreign material that could contribute to the reported events.Longevity assessment was performed based on average drain current and the device exceeded projected longevity indicating normal battery depletion.
Event or Problem Description
New information received notes that the patient was stable throughout.

• 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: 19512735
• Report Number: 2017865-2024-56201
• Device Sequence Number: 3418641
• Product Code: DXY
• UDI-Device Identifier: 05414734006903
• UDI-Public: 05414734006903
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 10/08/2024

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: 11/30/2008
• Device Model Number: 5386
• Device Lot Number: 0002122727
• 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: 05/23/2024
• Supplement Date Received by Manufacturer: 08/23/2024; 09/17/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 09/17/2024; 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2007
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male