MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD SMALL-S, 75 CM; NO MATCH

Model Number	1456Q/75
Medical Device Problem Codes	Break (1069); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for an implant procedure.During the procedure, the left ventricular (lv) lead failed to be separated from the stylet.In the attempt to pull the stylet out, the physician damaged the connector portion of the lv lead.The lv lead was not used and was replaced during the procedure.The patient was stable.
Additional Manufacturer Narrative
The reported events of break and separation failure were confirmed.As received, a complete lead was returned in one piece with the stylet stuck inside the lead.Visual inspection of the lead revealed that the connector pin and connector cap had been pulled out of the connector assembly, along with the inner coil.This is consistent with procedural damage.Additionally, the ptfe stylet coating was clogged with the inner coil distal to the connector pin.The cause of the reported events was a bunched-up ptfe coating on the stylet, which prevented its removal.Excessive forces resulted in the connector pin and cap being pulled out of the connector assembly.A device history record (dhr) review was performed, and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: QUARTET LEAD SMALL-S, 75 CM
• 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: 22199828
• Report Number: 2017865-2025-87236
• Device Sequence Number: 12451484
• Product Code: NIK
• UDI-Device Identifier: 05414734510141
• UDI-Public: (01)05414734510141(10)A000168160(17)271231
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/01/2025

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 Model Number: 1456Q/75
• Device Lot Number: A000168160
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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: 68 YR
• Patient Sex: Female