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

Model Number	PM1172
Medical Device Problem Code	Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pacemaker was found to be in backup vvi mode during device interrogation at the time of configuration.The pacemaker was not used and was replaced, and there was no patient involvement.

• Brand Name: ENDURITY MRI PACEMAKER, SR
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24242534
• Report Number: 2017865-2026-02078
• Device Sequence Number: 21237176
• Product Code: LWP
• UDI-Device Identifier: 05414734509596
• UDI-Public: (01)05414734509596(10)A000164187(17)260430
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2026

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 Expiration Date: 04/30/2026
• Device Model Number: PM1172
• Device Lot Number: A000164187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 03/30/2026; 05/29/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/31/2026; 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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