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

Model Number 1458Q/86

Device Problems Failure to Capture (1081); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

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

Event Date 02/02/2024

Event Type  Injury  

Event Description

Related manufacturing reference number: 2017865-2024-33190, related manufacturing reference number: 2017865-2024-33191.It was reported that the left ventricular lead exhibited loss of capture.Dislodgement was confirmed via x-ray.The physician decided to revise the lead.When the physician attempted to reposition the lead, it was noted the guidewire was unable to advance through the lead.The lead was explanted and replaced.When the new lead was plugged into the chronic implantable cardioverter defibrillator (icd), it was noted there was loss of capture, high pacing impedance, and the set screw had stripped.The icd was removed and replaced.When the new icd was implanted, it was noted the set screw on the right ventricular header could not be removed.The icd was removed and replaced successfully.The patient was stable.

Manufacturer Narrative

The reported events were lead dislodgement, failure to advance guidewire, and failure to capture.Final analysis found a complete lead was returned in one piece.The s-curve height was measured within specification.The reported event of failure to advance guidewire was confirmed.The guidewire could not be inserted beyond the middle region.Dissection of the lead found blood inside the inner coil.The reported event of failure to capture was not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.The cause of failure to advance guidewire was due to blood inside the inner coil.

• Brand Name: QUARTET
• 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: 18751542
• MDR Text Key: 335931179
• Report Number: 2017865-2024-33189
• Device Sequence Number: 1
• Product Code: NIK
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1458Q/86
• Device Lot Number: A000143773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2023
• 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: 2088TC/52 TENDRIL STS LEADS; 7122Q/58 DURATA TACHY MRI LEADS
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female