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

Model Number	PM2172
Medical Device Problem Code	Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During implant procedure, the device was interrogated and was found in back up mode.The device was not implanted and a new device was successfully implanted to resolve this event.The patient was stable with no consequence.

• 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: 25382166
• Report Number: 2017865-2026-11522
• Device Sequence Number: 15822420
• Product Code: LWP
• UDI-Device Identifier: 05414734509602
• UDI-Public: (01)05414734509602(10)P000249838(17)270731
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026

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: P000249838
• 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: 05/13/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2026
• 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