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 Retraction Problem (1536); Inappropriate/Inadequate Shock/Stimulation (1574); Device Dislodged or Dislocated (2923)

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

Event Date 08/31/2023

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic following continuous discharge (inappropriate shock).He was sent to a different facility on (b)(6) 2023.Testing revealed the right ventricular (rv) lead was dislodged.A procedure was performed on (b)(6) 2023 where an attempt to reposition the rv lead was made but the lead helix could not be retracted, leading to the rv lead being explanted and replaced.The patient was stable.

Manufacturer Narrative

The reported events were lead dislodgement, helix mechanism issue and inappropriate shock stimulation.A complete lead was returned in one piece with the helix found stretched/bent and clogged with dried blood.The reported event of helix mechanism issue was confirmed.X-ray inspection found the helix stretched/bent consistent with procedural damage.Unable to perform helix mechanism and extension length test due to damage helix as received.The cause of the reported event of helix mechanism issue was isolated to the helix bent and clogged with dried blood/tissue.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual and x-ray inspections of the lead did not find any anomalies except for procedural damage.

Manufacturer Narrative

Correction: section e1 physician name updated.

• 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: 17783358
• MDR Text Key: 323862682
• Report Number: 2017865-2023-46589
• 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,Followup
• Report Date: 11/07/2023

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: A000123607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 10/02/2023; 11/07/2023
• Supplement Dates FDA Received: 10/03/2023; 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2022
• 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