MAUDE Adverse Event Report: MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 6947

Device Problems Low Sensing Threshold (2575); Impedance Problem (2950)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This rv lead was implanted on (b)(6) 2018 and was explanted on (b)(6) 2018 due to out of range impedance and high pacing threshold.The physician was dr.(b)(6) at (b)(6) hospital in (b)(6).No other information is available.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17519674
• MDR Text Key: 321319836
• Report Number: MW5126622
• Device Sequence Number: 1
• Product Code: LWS
• 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: 10/17/2018

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: 6947
• Patient Sequence Number: 1