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

Model Number	PM1172
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
It was reported that the patient presented to hospital for an implant procedure.During the procedure, while connecting the lead to the pacemaker, a fault was identified with the pacemaker set screw upon tightening.The pacemaker was not used and replaced on (b)(6) 2026.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of the v setscrew mechanism being faulty was not confirmed.During ate testing the v setscrew was tightened without any complications and the device was analyzed.The device passed the ate test indicating normal output.The setscrew was normal and not stripped.The cause of the v setscrew mechanism problem could not be determined.

• Brand Name: ENDURITY MRI PACEMAKER, SR
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24634607
• Report Number: 2017865-2026-05700
• Device Sequence Number: 12910455
• Product Code: LWP
• UDI-Device Identifier: 05414734509596
• UDI-Public: (01)05414734509596(10)P000241488(17)270331
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P140033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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 Model Number: PM1172
• Device Lot Number: P000241488
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2025
• 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