MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) ASSURITY + DR RF; Pulse generator, permanent, implantable

Model Number	PM2260
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for a routine device change procedure.During the procedure, it was noted that the pacemaker was encapsulated in calcification, resulting in difficulty to remove the right ventricular (rv) and right atrial (ra) leads from the header of the pacemaker.Significant force was required, and a metal tool was used to detach the ra lead.This resulted in damage to the part of the ra lead that connects to the header.The damage was identified when the physician attempted to connect the ra lead to the header of the new pacemaker.The ra lead was then capped on (b)(6) 2026, and the new pacemaker was programmed to vvi mode.The old pacemaker was explanted and replaced successfully, while the rv lead remained implanted.The patient remained stable throughout the procedure.

• Brand Name: ASSURITY + DR 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: 24795836
• Report Number: 2017865-2026-07111
• Device Sequence Number: 18526075
• Product Code: NVZ
• UDI-Device Identifier: 05414734507097
• UDI-Public: (01)05414734507097(10)4620381(17)151130
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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: 11/30/2015
• Device Model Number: PM2260
• Device Lot Number: 4620381
• 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: 03/19/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2014
• 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
• Patient Sex: Unknown