MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) ASSURITY SR RF; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	PM1240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Heart Failure/Congestive Heart Failure (4446)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
It was reported that the patient presented for a pacemaker explant procedure.Prior to the procedure, the patient was noted to have a high percentage of right ventricular (rv) pacing (78%), which raised suspicion of rv pacing¿induced cardiomyopathy.The pacemaker was explanted and replaced.The patient status was unknown.
Additional Manufacturer Narrative
The reported adverse event could not be confirmed.The device voltage was above elective replacement indicator (eri) level upon receipt.Visual inspection found no anomaly on the header.Analysis of the device image indicated the device was within normal range of operation.Further analysis performed, including vibration and temperature cycle testing, found no anomaly.Longevity assessment found battery voltage above the elective replacement indicator (eri) voltage with appropriate remaining longevity.

• Brand Name: ASSURITY SR RF
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 25326045
• Report Number: 2017865-2026-11156
• Device Sequence Number: 21274142
• Product Code: NVZ
• UDI-Device Identifier: 05414734507066
• UDI-Public: (01)05414734507066(10)4887668(17)160531
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: PM1240
• Device Lot Number: 4887668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/04/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2014
• 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: TENDRIL LEAD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male