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

Model Number 7122Q/58

Device Problems Failure to Capture (1081); Difficult to Fold, Unfold or Collapse (1254); Retraction Problem (1536)

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

Event Date 03/05/2024

Event Type  Injury  

Event Description

It was reported the patient presented for a post implant check in the hospital.Interrogation revealed the right ventricular lead exhibited a loss of capture.A lead revision was attempted; it was observed that the lead helix could not extend or retract normally.The lead was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported events were helix mechanism issue and failure to capture.The reported event helix mechanism issue was confirmed.A complete lead was returned in one piece with a stylet inserted.The lead was returned with the helix extended and clogged with blood/tissue.X-ray inspection found the inner coil over torqued at the connector region consistent with procedure damage.X-ray examination of the helix mechanism found no anomalies or distortion of the helix that would have contributed to helix mechanism issue reported in the field.The reported event failure to capture was not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.The cause of the reported event helix mechanism issue was isolated to blood/tissue in the helix region and over torque of the inner coil.The inner coil and helix were damaged during analysis.

• 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: 18951095
• MDR Text Key: 338258056
• Report Number: 2017865-2024-35562
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503174
• UDI-Public: 05414734503174
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 7122Q/58
• Device Lot Number: A000109183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• 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.; QUARTET.; TENDRIL.
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male