MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE QUADRA RF CRT-P; NO MATCH

Model Number	PM3242
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pacemaker dependent patient presented for a generator change procedure.It was noted that the patient's left ventricular (lv) failed to capture from the time of its initial implant and had not been utilized since then.During the procedure, it was noted that the right ventricular (rv) lead failed to be removed from the pacemaker header.The physician used excessive technique to remove the rv lead and it was noted that the rv lead exhibited insulation damage.To complete the procedure, the physician cut, capped and replaced the rv lead during the procedure on (b)(6) 2025.The old lv lead was plugged into the new pacemaker and not utilized.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of the ventricular lead could not be removed from the header was confirmed.Analysis revealed this device has the original scalable brady pacemaker (sbp) header design, which is known to have lead insertion and removal difficulties.This caused the ventricular lead to become stuck in the header.This shows the high abnormal force needed to remove leads from the connectors of the original sbp header design.

• Brand Name: ALLURE QUADRA RF CRT-P
• Common Device Name: NO MATCH
• 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: 22333662
• Report Number: 2017865-2025-89178
• Device Sequence Number: 21065514
• Product Code: NIK
• UDI-Device Identifier: 05414734507912
• UDI-Public: (01)05414734507912(10)4591381(17)151031
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• 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): 07/29/2025

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: 10/31/2015
• Device Model Number: PM3242
• Device Lot Number: 4591381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2014
• 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 STS LEAD
• Patient Sex: Female