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

Model Number 1458Q/86

Device Problem Failure to Capture (1081)

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

Event Date 04/01/2024

Event Type  Injury  

Event Description

It was reported that the patient presented for a routine device change out procedure.Prior to the procedure, upon review, it was noted that the left ventricular (lv) lead exhibited failure to capture and high capture thresholds.Additionally, it was noted that the lv lead exhibited chronically elevated capture thresholds since implant.The lead was explanted and replaced.Patient was in stable condition.

Manufacturer Narrative

The reported event of failure to capture was not confirmed.As received, a partial distal portion of the lead was returned in one piece.Electrical testing and x-ray examination did not find any indication of conductor fractures or internal shorts.Visual inspection of the lead did not find any anomalies except for the damages found consistent with procedural damage.The s-curve height was measured within specification.

• 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: 19120199
• MDR Text Key: 340338715
• Report Number: 2017865-2024-38548
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: (01)05414734503198(10)A000098591(17)230630
• 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: 05/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 1458Q/86
• Device Lot Number: A000098591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2020
• 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: OPTISURE MRI; QUADRA ASSURA; TENDRIL
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male