MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC SPINAL CORD STIMULATOR

Device Problem Positioning Problem (3009)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 11/20/2017

Event Type  Injury  

Event Description

Went in to have the temporary medtronic's stimulator placed for a week to see if it would work.Only on electrode could be placed and the other one would not go in.Mri of my back was provided the dr prior to the event showing extensive damge from aging.When the one electrode was placed, pain like i never had in my lifetime occurred.I could not stop screaming in pain in the foot.Then dr finally said go to the emergency room as he totally removed the device from my back.We got in the car and my husband drove 20 miles to the emergency room.I could not walk, the pain in the foot, (referred pain) was so severe, just touching lightly sent me through the roof in pain screaming.I was admitted to the hospital and two days later, after my husband demanded a neuro consult to the vice president of the hospital, a neuro came in.The neuro surgeon stated i was not a candidate for this procedure.That the damage in the back was such it would not allow the electrodes to be placed safely.He prescribed gabapentin and 8 hrs after taking that the pain of two days finally began to subside allowing me to leave the hospital.It is clear, that depending on the extent of damage in a persons back, that this device cannot be used and damage to spinal cord can result when the electrodes are forced into the damaged area.

• Brand Name: MEDTRONIC SPINAL CORD STIMULATOR
• Type of Device: MEDTRONIC SPINAL CORD STIMULATOR
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 7100797
• MDR Text Key: 94400666
• Report Number: MW5073837
• 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
• Type of Report: Initial
• Report Date: 12/06/2017

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 91