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 Disconnect (2541)

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

Event Date 08/29/2023

Event Type  Injury  

Event Description

Related manufacturing reference number: 2017865-2023-45337.Related manufacturing reference number: 2017865-2023-45340.It was reported that the patient presented in clinic for a follow-up.Upon interrogation, it was noted that the right ventricular (rv) lead exhibited high capture threshold and the left ventricular (lv) lead exhibited loss of capture.The physician decided to explant and replace both leads.During the procedure, it was noted that the right atrial (ra) lead was attached to the rv and lv leads.The leads were all explanted and the rv and lv leads were replaced.The patient was in stable condition.

Manufacturer Narrative

The reported event of failure to capture was confirmed.Final analysis found only the distal portion of the lead was returned in one piece for analysis.Visual inspection found an external insulation abrasion breaching the inner coil lumen, ring electrode cable lumen 2 and ring electrode cable lumen 3 consistent with friction to another implanted device or feature of the patient anatomy proximal to the s-curve region.The etfe cable coating of the ring electrode 3 conductor path was found abraded in this location.The cause of failure to capture was isolated to the exposure of the inner coil and ring electrode cable conductor at the abrasion location.

• 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: 17770164
• MDR Text Key: 323679959
• Report Number: 2017865-2023-45338
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• 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: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: 1458Q/86
• Device Lot Number: 3810805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2012
• 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: CDHFA300Q ENTRANT HF.
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female