MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) ENDURITY MRI; Implantable pulse generator, pacemaker (non-CRT)

Model Number	PM2172
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Heart Failure/Congestive Heart Failure (4446); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pacemaker pacing rate was temporary reprogrammed for a surgery and after the operation was done, the device was returned back to original mode.It was alleged by a patient family member that the temporary change in pacing rate had induced acute heart failure, aggravated pleural effusion, and lead to deterioration of cardiac function and made the patient extremely weak.No further information was available.

• 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: 25163688
• Report Number: 2017865-2026-10007
• Device Sequence Number: 12920192
• Product Code: LWP
• UDI-Device Identifier: 05414734509602
• UDI-Public: (01)05414734509602(10)P000145784(17)231031
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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: 10/31/2023
• Device Model Number: PM2172
• Device Lot Number: P000145784
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2022
• 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