MAUDE Adverse Event Report: ABBOTT ENDURITY MRI PACEMAKER, SR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	PM1172
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device was explanted and replaced as it is subject to the assurity, endurity inhomogeneous epoxy mixing field safety correction action which applies to a subset of devices distributed and implanted outside of the united states.The patient was stable and will continue to be monitored.
Additional Manufacturer Narrative
The device was returned due safety advisory without identified device or use problem.The device was received with normal telemetry and normal output.Analysis performed did not find any anomalies.A longevity assessment found the device was operating above the elective replacement indicator (eri) voltage with appropriate remaining longevity.During analysis, a failure event was observed which was unrelated to the reported event.Final analysis through visual inspection of the header attachment area detected an anomaly between the pre-casted header and titanium case.A feedthrough leak test was performed, indicating a device hermeticity breach.Hybrid circuitry was tested by connecting to an external power source.Test results indicated normal current drain.A manufacturing process anomaly consistent with header bonding anomaly may have occurred.The device is included in the field action for assurity, endurity inhomogeneous epoxy mixing issued by abbott on 18 feb 2025 for a subset of devices distributed and implanted outside of the united states.

• Brand Name: ENDURITY MRI PACEMAKER, SR
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 23820646
• Report Number: 2017865-2025-1007108
• Device Sequence Number: 13108122
• Product Code: LWP
• UDI-Device Identifier: 05414734509596
• UDI-Public: (01)05414734509596(10)P000091801(17)210430
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P140033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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
• Report Date (Section B): 03/09/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: PM1172
• Device Lot Number: P000091801
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2019
• 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: Other
• Patient Sex: Unknown