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

Model Number D354DRG

Device Problem Pocket Stimulation (1463)

Patient Problems Burning Sensation (2146); Discomfort (2330)

Event Type  Injury  

Event Description

This device was implanted on (b)(6) 2005 and remains implanted at this time.It was noted on (b)(6) 2012 that patient felt discomfort on the pocket area.Noted that patient unable to tolerate settings, complaint of side effects of stimulation and felt a burning sensation in the pocket area.The physician was unknown.The healthcare facility was (b)(6) hospital in netherlands.No additional information 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: 17517609
• MDR Text Key: 321050087
• Report Number: MW5124557
• 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: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: D354DRG
• Patient Sequence Number: 1