MAUDE Adverse Event Report: MEDTRONIC CARDIAC PACING LEAD; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number DTBBLDL

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)

Patient Problem Shock from Patient Lead(s) (3162)

Event Type  malfunction  

Event Description

It was reported that this patient was previously using a saw that was plugged into an extension cord that was not properly grounded and received multiple inappropriate shocks from their previous cardiac resynchronization therapy defibrillator (crt-d) device.This device is not a boston scientific product.The specific date of this incident is unknown.The device was subsequently explanted and replaced for normal battery depletion.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: CARDIAC PACING LEAD
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17533866
• MDR Text Key: 321446208
• Report Number: MW5140769
• 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: 10/12/2021

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: DTBBLDL
• Patient Sequence Number: 1