MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) ENDURITY MRI; Implantable Pulse Generator, Pacemaker (Non-Crt)

Model Number	PM2172
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Failure to Disconnect (2541); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for an implant procedure.During the procedure, insulation breach was noted on the right ventricular (rv) lead.The lead was attempted to be removed, however during removal attempt, the set screw on the pacemaker's header got stripped, preventing the lead from being disconnected and reconnected to the header.The pacemaker and the rv lead were not used, and a new pacemaker and rv lead was implanted.The patient was stable throughout.

• Brand Name: ENDURITY MRI
• 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: 50797356
• Report Number: 2017865-2026-19731
• Device Sequence Number: 21213531
• Product Code: LWP
• UDI-Device Identifier: 05414734509602
• UDI-Public: (01)05414734509602(10)P000258242(17)271130
• 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): 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): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PM2172
• Device Lot Number: P000258242
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2026
• 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
• Patient Sex: Unknown