MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ENDURITY DR; Pulse generator, permanent, implantable

Model Number	PM2160
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A 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.
Event or Problem Description
Related manufacturer reference number: 2017865-2025-16867.It was reported that premature battery depletion was noted on the implantable cardioverter defibrillator (icd).The physician elected to explant and replace the icd.During the procedure, the left ventricular (lv) lead failed to be separated from the guidewire.The physician elected to not use the lead, and a new one was implanted.The patient condition was stable.

• Brand Name: ENDURITY DR
• 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: 21574078
• Report Number: 2017865-2025-16868
• Device Sequence Number: 8940935
• Product Code: NVZ
• UDI-Device Identifier: 05414734507059
• UDI-Public: (01)05414734507059(10)P000150311(17)240131
• 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: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/11/2025

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: 01/31/2024
• Device Model Number: PM2160
• Device Lot Number: P000150311
• Was Device Available for Evaluation?: No
• 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: 02/19/2025
• Initial Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2022
• 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