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	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for a follow up in clinic.It was noted that at the last follow in june, 2022 the remaining longevity estimate was about 2 years but after 8 months the pacemaker seemed to have reached end of life (eol).Premature battery depletion was suspected by the physician, though the device was implanted for 15 years.The physician was concerned managing and following up the patient may be difficult due to the change in battery longevity.The pacemaker was explanted and replaced.The patient was stable.
Additional Manufacturer Narrative
The reported event of ¿premature discharge of battery¿ couldn¿t be confirmed.The device was at end of service and not able to be interrogated when it was received.The device image could not be saved due to low battery voltage from normal usage.Analysis performed after installing a known good battery and did not find any anomalies.Further evaluation under various pulse amplitudes measured current levels within normal range, and no indication of premature depletion was noted.The implant duration exceeded the device¿s projected longevity and is considered normal battery depletion.

• 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: 16457266
• Report Number: 2017865-2023-11376
• Device Sequence Number: 6458464
• Product Code: DXY
• UDI-Device Identifier: 05414734006903
• UDI-Public: 05414734006903
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2023

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: 12/31/2008
• Device Model Number: 5386
• Device Catalogue Number: 5386
• Device Lot Number: 0002218470
• 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: 02/10/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2007
• 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 Sex: Unknown