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

Model Number 7121Q/58

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

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

Event Date 02/26/2024

Event Type  Injury  

Event Description

It was reported the patient presented in clinic for follow up.Upon interrogation, it was discovered the right ventricular lead exhibited high pacing impedance and a loss of capture.No changes or intervention was reported.The patient was in stable condition.

Event Description

Additional information received indicated the lead exhibited a fracture and again exhibited high pacing impedance.The lead was capped and replaced (b)(6) 2024.The patient was in stable condition.

• 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: 18874944
• MDR Text Key: 337549622
• Report Number: 2017865-2024-34551
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503167
• UDI-Public: 05414734503167
• 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
• Report Date: 04/08/2024

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 Expiration Date: 12/31/2010
• Device Model Number: 7121Q/58
• Device Lot Number: 2898632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2009
• 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: ELLIPSE
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male