MAUDE Adverse Event Report: ST. JUDE MEDICAL PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 7122Q

Device Problems Failure to Capture (1081); Failure to Sense (1559); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 12/14/2016

Event Type  malfunction  

Event Description

This lead was implanted on (b)(6) 2015 and still remains implanted at this time.On (b)(6) 2016, lead displacement was observed.There was no sensing and no capture in the right ventricle.The lead will be extracted soon.The physician was dr.(b)(6).No other information available.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): ST. JUDE MEDICAL
• MDR Report Key: 17527805
• MDR Text Key: 321430646
• Report Number: MW5134736
• 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: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 7122Q
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1