MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Assurity RF DR; Pulse Generator, Permanent, Implantable

Model Number	PM2240
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for a generator change procedure.During the procedure, it was noted that the right ventricular (rv) lead and right atrial (ra) lead could not be removed from the pacemaker header.The physician injected saline into the pacemaker header in an attempt to remove the leads.The ra lead was eventually removed; however, the insulation of the rv lead was damaged, and the rv lead could not be removed from the pacemaker header.The physician subsequently capped the rv lead.The existing ra lead and a new rv lead were connected to the new pacemaker, and the old pacemaker was explanted.The patient remained in stable condition throughout the procedure.

• Brand Name: Assurity RF DR
• 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: 50685317
• Report Number: 2017865-2026-19004
• Device Sequence Number: 5279305
• Product Code: NVZ
• UDI-Device Identifier: 05414734507073
• UDI-Public: (01)05414734507073(10)4755095(17)160229
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: 02/29/2016
• Device Model Number: PM2240
• Device Lot Number: 4755095
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2014
• 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 Age: 71 YR
• Patient Sex: Male