MAUDE Adverse Event Report: MEDTRONIC NEUROSTIMULATOR; NONE

Model Number 37751

Device Problem Battery Problem (2885)

Patient Problems Arthritis (1723); Pain (1994); Weakness (2145); Ambulation Difficulties (2544); Alteration In Body Temperature (2682)

Event Date 09/22/2014

Event Type  Other  

Event Description

I had a metronic neurostimulator implanted in (b)(6) 2014 then my legs became weak, joints feel like i have arthritis, had chronic low grade temp, burning at battery and pain every where leads, battery and paddle implanted, had so much weakness in my legs that i was having trouble walking and had to have it removed at another facility in (b)(6) 2014 and still having arthritic symptoms and back pain.

• Brand Name: NEUROSTIMULATOR
• Type of Device: NONE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 4190278
• MDR Text Key: 5095058
• Report Number: MW5038693
• Device Sequence Number: 1
• Product Code: MHY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 37751
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2014
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 82