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

Model Number 7122Q/65

Device Problems Failure to Capture (1081); Retraction Problem (1536); Device Dislodged or Dislocated (2923)

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

Event Date 02/18/2024

Event Type  Injury  

Event Description

It was reported that the patient presented for a follow-up in clinic.Review of the device records noted high capture thresholds on the right ventricular (rv) lead which led to loss of capture.A chest x-ray performed noted a slight change in the position of the rv lead, leading the physician to suspect the rv lead was dislodged.The patient was asymptomatic.The physician tried repositioning the rv lead, but the helix failed to retract.The rv lead was explanted and replaced successfully.The patient is recovering.

Manufacturer Narrative

The reported events were lead dislodgement, helix mechanism issue and failure to capture.As received, a complete lead was returned in one piece with the helix found extended/bent and clogged with blood/tissue.The reported event of helix mechanism issue was confirmed.X-ray inspection found overtorque of the inner coil at the connector region consistent with procedural damage, and found that the helix stretched/bent, also consistent with procedural damage.The cause of the reported event of helix mechanism issue was isolated to blood/tissue and stretched/bent of the helix in the helix region and overtorqued of the inner coil.The reported event of failure to capture was not confirmed.Analysis was normal.No anomalies were found.

• 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: 18777334
• MDR Text Key: 336201294
• Report Number: 2017865-2024-33440
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7122Q/65
• Device Lot Number: A000145256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2023
• 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
• Patient Outcome(s): Required Intervention