MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ACCENT SR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	PM1110
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient presented with high capture thresholds noted on the right ventricular lead, and premature battery depletion noted on the patient's implantable cardioverter defibrillator.The lead was capped, and the device was explanted and replaced.This intervention occurred on (b)(6) 2025.No adverse patient consequences were reported.
Additional Manufacturer Narrative
Device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.
Additional Manufacturer Narrative
The reported events of premature discharge of battery was not confirmed.The device was above elective replacement indicator (eri) level upon receipt.Device image indicated that device was programmed to high field settings.Analysis performed in nominal settings did not show any anomalies.Longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.
Event or Problem Description
It was reported that a patient presented with high capture thresholds noted on the right ventricular lead, and premature battery depletion noted on the patient's pacemaker.The lead was capped, and the device was explanted and replaced.This intervention occurred on (b)(6) 2025.No adverse patient consequences were reported.

• Brand Name: ACCENT SR
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 22900742
• Report Number: 2017865-2025-98688
• Device Sequence Number: 15718660
• Product Code: NVZ
• UDI-Device Identifier: 05414734502740
• UDI-Public: (01)05414734502740(10)S000067407(17)200630
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 03/31/2026

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: 06/30/2020
• Device Model Number: PM1110
• Device Lot Number: S000067407
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 09/04/2025; 02/27/2026; 03/26/2026
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/04/2025; 03/18/2026; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2019
• 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