MAUDE Adverse Event Report: MEDTRONIC PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 4074

Device Problem Battery Problem (2885)

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

Event Date 07/18/2012

Event Type  malfunction  

Event Description

Boston scientific received information, that during the follow- international up appointment.It was identified that since the last device check, the device had lost 18 months of battery life.High threshold measurements were noted on the competitor atrial and ventricular leads.No adverse patient effects were reported.Dr.(b)(6).Event date (b)(6) 2012.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERMANENT DEFIBRILLATOR ELECTRODES
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17528132
• MDR Text Key: 321408961
• Report Number: MW5135063
• 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
• Report Date: 08/10/2012

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: 4074
• Patient Sequence Number: 1