MAUDE Adverse Event Report: UNKNOWN SPINAL CORD STIMULATOR

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Headache (1880); Shock (2072); Discomfort (2330); Inadequate Pain Relief (2388)

Event Date 03/15/2013

Event Type  Injury  

Event Description

(b)(4).It was suggested from pain management and my orthopedic surgeon to try the stimulator to control my severe pain, i went in for the trial.The o.D.And the salesmen from medtronics were in the operating room they numbed the surgical area and proceeded to put wires while i was hooked up to a machine, i went home with much discomfort , i was surprised and disturbed that a non doctor would be adjusting the pain device it seemed an unsanitary atmosphere, he did the best he could to explain my husband was in the room also.I had strange feelings in the vaginal area i felt i was being electrocuted or zapped! i had severe headache increased awareness of the pain caused by back surgery, the salesman called me a couple of times i answered all questions i thought something was wrong so we made arrangements to meet back at pain management to adjust it another person showed up that i had never met before and just started adjusting the power level of the wires to my spine and i was so terrified at that point that i demanded that they remove it that it was affecting my bowel and my urinary control.I had many complications but it was hard to tell because the original surgery was such a failure and i was always at a level 10 pain at all times it just seemed i was in constant pressure from any medical people to use the medtronics products.

• Brand Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 6890572
• MDR Text Key: 87217918
• Report Number: MW5072378
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OXYCODONE, METHADONE, HYDROCODONE, GABAPENTIN,
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 41.000 YR