MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY + DR RF; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	PM2260
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an elective generator change.During the procedure, it was noted that the leads were stuck to the header of the pacemaker (pm); the physician deconstructed the header to remove the leads.The pm was explanted and replaced.The patient condition was stable.
Additional Manufacturer Narrative
The reported event of could not remove the atrial and ventricular leads from the header was unconfirmed.The cause of the problem cannot be determined.The header was broken apart into too many pieces by the physician.No measurements could be performed.No anomalies could be found due to the extensive damage to the connectors by the physician.
Additional Manufacturer Narrative
The reported event of could not remove the atrial and ventricular leads from the header was confirmed.Analysis revealed there was blood accumulation in the atrial and ventricular 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 which made the lead difficult to remove.The setscrew had no effect on lead removal since it had been untightened normally by the physician and the lead still was difficult to remove from the header.The blood was most likely not cleaned from the proximal ends of the leads before they were inserted into the connector at time of implant.

• Brand Name: ASSURITY + DR RF
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 21471182
• Report Number: 2017865-2025-15176
• Device Sequence Number: 3390933
• Product Code: NVZ
• UDI-Device Identifier: 05414734507097
• UDI-Public: (01)05414734507097(10)P000000326(17)160731
• 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: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2025

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: 07/31/2016
• Device Model Number: PM2260
• Device Lot Number: P000000326
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 04/01/2025; 06/04/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 04/02/2025; 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2015
• 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 RA LEAD.; TENDRIL RV LEAD.
• Patient Sex: Unknown