MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 7122Q/52

Device Problems Fracture (1260); Over-Sensing (1438)

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

Event Date 03/04/2024

Event Type  Injury  

Event Description

It was reported that the patient presented remotely via merlin.Net.Upon review, it was found that patient's right ventricular (rv) lead exhibited noise oversensing.Programming changes were made.The patient was stable.

Manufacturer Narrative

The reported event of oversensing noise was confirmed.The reported event of lead fracture was not confirmed.As received, a complete lead was returned in two pieces.Electrical testing and x-ray examination did not find any indication of conductor fractures or internal shorts.An external insulation abrasion was found proximal to the suture sleeve breaching the ring electrode cable lumen cable coating.The cause of the reported event of oversensing noise was due to the external insulation abrasion breaching the ring electrode cable lumen and one ring electrode cable conductor also found to be abraded which is consistent with friction to the device can.

Event Description

New information received notes that lead fracture was noted.The lead was explanted and replaced.There were no patient consequences.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 18951521
• MDR Text Key: 338360808
• Report Number: 2017865-2024-35564
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503730
• UDI-Public: 05414734503730
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P950022
• 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,Followup,Followup
• Report Date: 05/01/2024

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: 10/31/2019
• Device Model Number: 7122Q/52
• Device Lot Number: A000067392
• 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: 03/04/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/01/2024; 04/16/2024; 05/01/2024
• Supplement Dates FDA Received: 04/18/2024; 04/22/2024; 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2018
• 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: QUADRAASSURA; QUARTET; TENDRIL
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female