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

Model Number 7120Q

Device Problems Battery Problem (2885); Charging Problem (2892); Output Problem (3005)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

It was reported that the patient's implantable cardioverter defibrillator (icd) battery became completely depleted and it was noticed it recorded both code 1004 and 1007, message indicators related to a shorted right ventricular (rv) lead circuit and shocking capacitors that are not charged to the programmed voltage 45 seconds after the start of charging.Reportedly, the rv lead impedance did not go out-of-range.Due to these issues, the patient received tachy therapy that could not convert the arrhythmia and eternal shocks had to be delivered.Technical services recommended to replace the icd and this rv lead as soon as possible as the patient's critical therapy is no longer guaranteed.Indicating these products were certainly damaged.Subsequently, the icd and this rv were explanted and replaced.No additional 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: 17532974
• MDR Text Key: 321161399
• Report Number: MW5139880
• 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: 7120Q
• Patient Sequence Number: 1