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); Inappropriate/Inadequate Shock/Stimulation (1574); Device Dislodged or Dislocated (2923)

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

Event Date 02/01/2024

Event Type  Injury  

Event Description

It was reported that the patient received inappropriate therapies.After device programming, it was found that no capture was noted on the right ventricular (rv) lead.A ct scan was performed, and dislodgement was found.During the rv lead revision, helix would not retract.The rv lead was replaced.There were no adverse health consequences, the patient was stable.

Manufacturer Narrative

The reported event of lead dislodgement, inappropriate shock, and failure to capture were not confirmed, while the reported event of helix mechanism issue was confirmed.As received, a complete lead was returned in one piece with the helix extended and clogged with blood.X-ray inspection found the inner coil was overtorqued at the connector region.The helix could be retracted and extended after cutting the lead, cleaning the distal region, and applying torque directly to the inner coil.The full helix extension length was measured within product specification.The cause of the helix mechanism issue was isolated to and overtorqued the inner coil, consistent with procedural damage and clogged helix.Electrical testing did not find any indication of conductor fractures or internal shorts.

• 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: 18743227
• MDR Text Key: 335788986
• Report Number: 2017865-2024-33110
• 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: 04/11/2024

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 Model Number: 7122Q/65
• Device Lot Number: A000142800
• 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: 02/01/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2023
• 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