MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD SMALL-S, 86 CM; NO MATCH

Model Number 1456Q/86

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

Related manufacturer report number: 2017865-2024-34242, related manufacturer report number: 2017865-2024-34243, related manufacturer report number: 2017865-2024-34248, related manufacturer report number: 2017865-2024-34251, related manufacturer report number: 2017865-2024-34254.It was reported during device upgrade that the right ventricular lead and atrial leads were stuck together, so both were explanted.A left ventricular lead was positioned but dislodged, as did its two replacements.During positioning attempts the newly implanted atrial lead was dislodged and had to be exchanged.A replacement right ventricular (rv) lead was positioned but dislodged.Attempt to reposition the rv lead was unsuccessful as the helix would not re-extend.The patient was stable.

Manufacturer Narrative

The reported event was lead dislodgement.As received, a complete lead was returned in one piece.Visual examination of the lead did not find any anomalies.The s-curve height was measured within specification.Electrical testing did not find any indication of conductor fractures or internal shorts.

• Brand Name: QUARTET LEAD SMALL-S, 86 CM
• Type of Device: 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18846903
• MDR Text Key: 337514862
• Report Number: 2017865-2024-34247
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510158
• UDI-Public: 05414734510158
• 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: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1456Q/86
• Device Lot Number: A000152969
• 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: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2024
• 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: GALLANT
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 75 KG