MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD DOUBLE BEND, 86 CM; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 1457Q/86

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2024

Event Type  malfunction  

Event Description

It was reported that the patient presented for a scheduled procedure.During the procedure, it was found that the left ventricular (lv) lead was failing to advance over the guidewire.The lv was not used.The physician continued with second lv lead and completed the procedure.The patient was in stable condition.

Manufacturer Narrative

The reported event of ¿the wire would not pass past the initial part of the lead¿ was confirmed.A complete lead was returned in one piece.The guidewire used in the field was not returned with the lead for analysis.The ptfe coating of the guidewire was found bunched up with the inner coil.Visual and x-ray examination of the lead found the inner coil inside the connector region was bunched up consistent with procedural damage.The guidewire insertion could not be tested due to the bunched up inner coil.The cause of the reported event was due to the bunched up inner coil inside the connector region caused by guidewire ptfe coating.Electrical testing did not find any indication of conductor fractures or internal shorts.

• Brand Name: QUARTET LEAD DOUBLE BEND, 86 CM
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18541073
• MDR Text Key: 333232587
• Report Number: 2017865-2024-01486
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734510189
• UDI-Public: 05414734510189
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1457Q/86
• Device Lot Number: A000141934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DURATA TACHY MRI LEAD; MRI CONDTENDRIL LEAD; QUADRA ASSURA ICD
• Patient Age: 63 YR
• Patient Sex: Female