MAUDE Adverse Event Report: ST. JUDE MEDICAL DURATA STS OPTIM ACTIVE FIXATION; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 7121

Device Problem Output Problem (3005)

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

Event Type  malfunction  

Event Description

It was reported that the right ventricular (rv) lead is having an issue.The lead remains in service.No adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17537047
• MDR Text Key: 321362529
• Report Number: MW5143929
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 7121
• Patient Sequence Number: 1