MAUDE Adverse Event Report: MEDTRONIC DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number C154

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Patient services received a call on (b)(6) 2012.Patient states that his device is beeping and they checked it with the representative and must have turned the sound down which makes him nervous that he can't hear it.States they said something about getting a monitor in his home to monitor the leads until the replacement and to call the company.Discussed with patient that his device is made by medtronic which is a separate company.Recommend further discussion with physician and to contact medtronic.Patient said his physician told him that the lead or leads will need to be replaced.He overheard physician talking to representative about the leads because they are failing and he could die.No additional information is available at this time.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17523370
• MDR Text Key: 321405934
• Report Number: MW5130318
• Device Sequence Number: 1
• Product Code: NIK
• 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: 07/13/2012

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: C154
• Patient Sequence Number: 1