MAUDE Adverse Event Report: MEDTRONIC IMPLANTABLE NEUROSTIMULATOR ; STIMULATOR, SPINAL-CORD

Model Number 97740

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Swelling (2091)

Event Date 09/01/2017

Event Type  Injury  

Event Description

Pt's husband called in to report that five weeks after wife got the medtronic neurostimulator implanted in her, she started having problems.One of the issue is on her back where the lead is implanted, and on her buttocks area where the battery is implanted are both massively inflamed.Pt can feel a mass where the implant is and the area is also warm to touch.Pt's husband believes the neurostimulator is causing a delayed hypersensitivity response.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6947539
• MDR Text Key: 89357194
• Report Number: MW5072744
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 97740
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Weight: 98