MAUDE Adverse Event Report: MEDTRONIC; NONE

Model Number 4076-52

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Low Battery (2584); Defective Device (2588)

Patient Problem Electric Shock (2554)

Event Date 04/02/2014

Event Type  Other  

Event Description

Medtronic implanted device 4076 and 4198 replaced on (b)(6) 2014 at (b)(6) hospital, (b)(6).I was taken by ambulance because the device shocked me twice at home and once at the hospital emergency room.Advised by doctor to go by ambulance to hospital.This is the second time i have had this device replaced.On december 20, 2010, battery died, replaced device.Know others who have different devices with no problems.When i arrived in the hospital emergency room, i was told that there are three technical people from medtronic to turn off devices.This is a problem! i feel that this is a defective product and no one cares to help the patient.(b)(4).

• Brand Name: MEDTRONIC
• Type of Device: NONE
• MDR Report Key: 4037501
• MDR Text Key: 4726017
• Report Number: MW5037888
• Device Sequence Number: 1
• Product Code: NVZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Device Operator: Other
• Device Model Number: 4076-52
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2014
• Patient Sequence Number: 1
• Patient Age: 65 YR