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 Break (1069); Difficult to Fold, Unfold or Collapse (1254); Retraction Problem (1536); Low impedance (2285); Capturing Problem (2891); Device Sensing Problem (2917)

Patient Problem Cardiac Perforation (2513)

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2023-42638.It was reported that the patient received inappropriate high voltage (hv) therapy from their implantable cardioverter defibrillator due to incorrect interpretation of signals.During follow-up in clinic, it was noted that the patient's right ventricular lead exhibited high capture threshold and impedance.R-waves were noted to be diminished.It was elected to revise the lead.During lead revision, the helix of the lead failed to be retracted and extended.It was alleged that the lead had perforated the cardiac tissue, resulting in the helix issue.The lead was explanted and replaced.The patient was stable.

Event Description

It was reported that the patient received inappropriate high voltage (hv) therapy from their implantable cardioverter defibrillator due to incorrect interpretation of signals.During follow-up in clinic, it was noted that the patient's right ventricular lead exhibited high capture threshold and low pacing impedance.R-waves were noted to be diminished.It was elected to revise the lead.During lead revision, the helix of the lead failed to be retracted and extended.It was alleged that the lead had perforated the cardiac tissue, resulting in the helix issue.The lead was explanted and replaced.The patient was stable.

Manufacturer Narrative

The reported event of damaged helix was confirmed and the reported events of high capture threshold and impedance were not confirmed.As received, a complete lead was returned in one piece.Final analysis found the helix was retracted and clogged with blood/tissue.X-ray examination found the inner coil in the connector region was over torqued due to procedural damage.No further anomalies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: 17716982
• MDR Text Key: 323035930
• Report Number: 2017865-2023-42639
• 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,Followup,Followup,Followup
• Report Date: 10/11/2023

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/58
• Device Lot Number: A000139415
• 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: 08/22/2023
• Initial Date FDA Received: 09/10/2023
• Supplement Dates Manufacturer Received: 09/11/2023; 09/22/2023; 10/03/2023
• Supplement Dates FDA Received: 09/13/2023; 09/26/2023; 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2023
• 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
• Treatment: TENDRIL.
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female