MAUDE Adverse Event Report: MEDTRONIC SPINAL CORD STIMULATOR

Model Number 97714

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 01/29/2016

Event Type  Injury  

Event Description

Caller was implanted with a spinal cord stimulator on (b)(6) 2016 for pain.On (b)(6) 2016, she met with her doctor and medtronic representation to turn on the stimulator.When the stimulator was turned on the stimulation was felt on the wrong side of the body.After several attempts it was decided the leads were placed in the wrong side of the body and will require a revision and a date was set for (b)(6) 2016.A week later caller was informed by the doctor that she may be referred to a neurosurgeon for the implant of a paddle instead of a lead stimulator.Caller said the surgeon stated that she should have had a pump rather than a spinal stimulator.On (b)(6) a revision of the lead took place but the paddle was not required.Caller was informed that the leads are okay but is required to be repositioned.Caller returned to the doctor's office to turn on the lead after revision and there was still a problem with stimulation.After several attempts, it was concluded that the client's scoliosis prevents the leads to work as intended because as she moves the leads also moves preventing stimulation.After several tests it was decided that a pump would be implanted and the stimulator will be explanted.Caller is still experiencing pain and the leads are still implanted.The leads cannot be used but it need to be charged from time to time until explant.Caller believe a 3rd surgery could have been avoided if her x-ray's were properly checked before surgery.It has now been determined that she would be a good candidate for a pump after a pump trial three weeks ago.

• Brand Name: SPINAL CORD STIMULATOR
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6553711
• MDR Text Key: 74822483
• Report Number: MW5069618
• Device Sequence Number: 1
• Product Code: GZB
• 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: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 97714
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 54