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	12/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the device is subject to the assurity and endurity pacemakers header anomaly advisory issued by abbott on 15 march 2021.The pacemaker was explanted and replaced.The patient is stable with no consequences.
Additional Manufacturer Narrative
The device was returned due safety advisory without identified device or use problem.The device was received with normal telemetry and output.Analysis performed did not identify any functional issues.Longevity assessment found the device was operating above the elective replacement indicator (eri) voltage with appropriate remaining longevity.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.Visual inspection of the header attachment area detected an anomaly between the epoxy header and titanium case.Feedthrough leak test was performed, indicating no sign of hermeticity breach.A manufacturing process anomaly may have occurred, which resulted in the header bonding anomaly.The device is included in the assurity and enduritypacemakers 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): 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: 23963113
• Report Number: 2017865-2026-00230
• Device Sequence Number: 15788478
• Product Code: LWP
• UDI-Device Identifier: 05414734509596
• UDI-Public: (01)05414734509596(10)A000014402(17)170531
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P140033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: 05/31/2017
• Device Model Number: PM1172
• Device Lot Number: A000014402
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2015
• 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-1531-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown