MAUDE Adverse Event Report: ABBOTT ASSURITY + DR RF; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	PM2260
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a routine device exchange, the set screws of the device were difficult to loosen resulting in difficulty removing the lead from the header of the device causing a significantly extended procedure time.The device was explanted and replaced to resolve this event.The patient was stable and did not experience any consequence due to the event.
Additional Manufacturer Narrative
The reported event of difficult time removing leads from the header was confirmed.Analysis revealed there was blood accumulation in the a- and v-connector port zones.The blood in these areas had a bonding effect between the inside areas of the connector ports and the surfaces of the lead body.This made the leads difficult to remove.The setscrews had no effect on lead removal since they were not stripped and had been untightened normally by the physician, and the lead still was difficult to remove from the header.The connector dimensions were normal.The blood was most likely not cleaned from the proximal ends of the lead before it was inserted into the connector at time of implant.

• Brand Name: ASSURITY + DR RF
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 22376099
• Report Number: 2017865-2025-91002
• Device Sequence Number: 11916415
• Product Code: NVZ
• UDI-Device Identifier: 05414734507097
• UDI-Public: (01)05414734507097(10)4869566(17)160531
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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: 05/31/2016
• Device Model Number: PM2260
• Device Lot Number: 4869566
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 10/05/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2014
• 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