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

Model Number	PM1272
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient's pacemaker exhibited far field r-wave over-sensing.No interventions or changes were reported.The patient's condition was unknown.
Additional Manufacturer Narrative
Further information was requested but not received.

• Brand Name: ASSURITY 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: 25225202
• Report Number: 2017865-2026-10540
• Device Sequence Number: 9801787
• Product Code: LWP
• UDI-Device Identifier: 05414734509572
• UDI-Public: (01)05414734509572(10)A000181082(17)270430
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P140033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: PM1272
• Device Lot Number: A000181082
• 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: 05/04/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ULTIPACE.
• Patient Age: 82 YR
• Patient Sex: Male