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

Model Number 7120Q/58

Device Problems Failure to Capture (1081); Fracture (1260); High impedance (1291); Failure to Sense (1559)

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

Event Date 09/15/2023

Event Type  Injury  

Event Description

It was reported that the implantable cardioverter defibrillator exhibited backup operation.It was noted that the capacitor maintenance timed out and there was an interrogation problem.It was also mentioned that the right ventricular lead exhibited failure to capture, failure to sense and high impedance due to fracture.The lead and the device were both explanted.The patient was in stable condition.

Manufacturer Narrative

The reported events of failure to capture, failure to sense, high pacing lead impedance and lead fracture were confirmed.As received, only the proximal portion of the lead was returned in one piece.A clavicular crush damage was found distal to the suture sleeve tie impression damaging the lead body and fracturing both the right ventricular and superior vena cava and one ring electrode cables and all the filars of the inner coil were found fractured and melted in this location.Unable to determine the actual length of the clavicular crush damage due to the other portion of the lead was missing/not returned for analysis.Electrical testing did not find any internal shorts.The cause of the reported events was due to the clavicular crush damage.

• 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: 17895582
• MDR Text Key: 325236913
• Report Number: 2017865-2023-48104
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734502818
• UDI-Public: 05414734502818
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

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 Expiration Date: 11/30/2015
• Device Model Number: 7120Q/58
• Device Lot Number: 4865536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2014
• 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
• Patient Age: 61 YR
• Patient Sex: Male