MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. IDENTITY ADX VDR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5480
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During the previous follow-up, approximately seven months ago, the battery longevity showed less than two years until elective replacement indicator (eri).However, during the most recent follow-up, the battery was now at eri.Premature battery depletion was suspected.Device replacement is anticipated.The patient was stable.
Event or Problem Description
New information was received indicating the device was explanted and replaced.The patient was stable.
Additional Manufacturer Narrative
The reported event of premature battery depletion was not confirmed.The device was received with battery voltage at elective replacement level which was reached post-explant.Device image indicated that auto-capture was enabled and operated in high output mode at times consistent with the false replacement alert triggered in the field.When automatic settings are programmed, such as auto-capture, the device output would adjust itself to accommodate the patient¿s needs for pacing and thus affect the estimated longevity of the device.Analysis performed, in nominal settings, and at various outputs, did not find any anomalies.Longevity assessment was performed, and the device exceeded projected longevity based on field settings indicating normal battery depletion.

• Brand Name: IDENTITY ADX VDR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13720075
• Report Number: 2017865-2022-04992
• Device Sequence Number: 4807403
• Product Code: LWP
• UDI-Device Identifier: 05414734006927
• UDI-Public: 05414734006927
• 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: 2013
• Device Explanted Year: 2022
• 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): 06/23/2022

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: 04/30/2014
• Device Model Number: 5480
• Device Catalogue Number: 5480
• Device Lot Number: 3835217
• 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: 02/23/2022
• Supplement Date Received by Manufacturer: 04/01/2022; 06/23/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 04/08/2022; 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2012
• 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