MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ENDURITY MRI PACEMAKER, SR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	PM1172
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
It was reported that the patient presented for in clinic follow-up.Device interrogation revealed premature battery depletion on the pacemaker (pm) and low out-of-range pacing impedance on the right ventricular (rv) lead.Additionally, no capture was noted on the rv lead.The physician explanted and replaced the pm and rv lead.The patient condition was stable.
Event or Problem Description
It was reported that the patient presented for in clinic follow-up.Device interrogation revealed premature battery depletion on the pacemaker (pm) and low out-of-range pacing impedance on the right ventricular (rv) lead.Additionally, no capture was noted on the rv lead.On (b)(6) 2026, the physician explanted and replaced the pm.The rv lead was capped and replaced that same day.The patient condition was stable.
Additional Manufacturer Narrative
Correction: section b5 - the rv lead was capped on (b)(6) 2026 and was not explanted as previously stated.
Additional Manufacturer Narrative
The reported events of premature battery depletion was confirmed.As received, the device had no telemetry communication and no output.Visual inspection of the header attachment area detected a bonding anomaly.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.A device hermeticity breach was observed, consistent with feedthrough damage as a result of fluid intrusion between the header and case, and subsequent fluid ingress to the internal electronics.The device was cut open to enable further testing and battery was found depleted.Hybrid circuitry was tested by connecting to an external power source.Test results indicated normal current drain.A manufacturing anomaly may have occurred, which resulted in the header bonding anomaly.The device is included in the assurity and endurity pacemakers' header anomaly advisory issued by abbott on 15 march 2021.

• Brand Name: ENDURITY MRI PACEMAKER, SR
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 24081620
• Report Number: 2017865-2026-01001
• Device Sequence Number: 5827650
• Product Code: LWP
• UDI-Device Identifier: 05414734509596
• UDI-Public: (01)05414734509596(10)A000047116(17)190531
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P140033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2026

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: 05/31/2019
• Device Model Number: PM1172
• Device Lot Number: A000047116
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 01/16/2026; 02/18/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 01/30/2026; 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1530-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown