MAUDE Adverse Event Report: BIOTRONIK PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 359067

Device Problem Battery Problem (2885)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-0) device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis showed the battery appeared to be depleting more quickly than expected.It was recommended to the healthcare provider (hcp) that the device be replaced and return to boston scientific for a detailed analysis.In addition, it was noted that the crt-d device exhibited intermittent high out of range pace impedance measurements greater than 2000 ohms on the right ventricular (rv) lead.The rv lead is not a boston scientific product.The device was subsequently explanted and replaced three days later.The rv lead remains in-service.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: PERMANENT DEFIBRILLATOR ELECTRODES
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 17523712
• MDR Text Key: 321145920
• Report Number: MW5130660
• 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: 07/07/2021

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: 359067
• Patient Sequence Number: 1