MAUDE Adverse Event Report: MEDTRONIC NEUROSTIMULATOR/SPINAL CORD STIMULATOR

Model Number 37714

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bruise/Contusion (1754); Erythema (1840); Hyperglycemia (1905); Pain (1994); Staphylococcus Aureus (2058); Sepsis (2067); Post Operative Wound Infection (2446); Limited Mobility Of The Implanted Joint (2671)

Event Date 12/01/2015

Event Type  Injury  

Event Description

On (b)(6) 3015, at (b)(6), dr (b)(6) implanted a spinal cord stimulator in my back and the battery was placed above the left buttock back area.The site was bulging and very painful to sit and lean back.The doctor said that was normal and it was the battery.However, it continued to be painful.Then 2 months ago, i had excruciating pain and i went to the neurosurgeon, dr (b)(6) and he said no wonder i was in pain, the battery shifted out of place.He booked the repositioning surgery to move from back to left side on (b)(6) 2015.I had that surgery.I was there all day for a minor surgery because the nurse was splashed with spinal cord fluid in her face.They had to run bloodwork on me for her safety.I was released same day.On (b)(6) 2015, i had a 101 fever and could hardly move.On (b)(6) 2015, i was moving better but then at 11 am, i had 101.8 fever, my sugars spiked and i had excruciating pain at the left side incision.The back incision was fine.My mother called 911 and i went to (b)(6) medical center.By the time i got looked at by the er doctor, not even a half hour later, the site was red, hot to touch, very painful and the redness widened.She said it was infected, gave me iv antibiotic did bloodwork and called doctor (b)(6) in (b)(6) (he doesn't go to (b)(6)).(b)(6) partner said to discharge and have me go into the office on friday afternoon (b)(6) 2015, which i did.(b)(6) looked at it and told us it was not infected but bruised, and he is not saying i don't have an infection elsewhere but he discounted a site infection.He was more concerned with sugars.He said we can go home or try to go to (b)(6).We elected to go and my parents drove right to the er.Two doctors said it was infected and then they told me i had sepsis and had icu doctors who said it was infected and not bruised.They ordered a stat ultrasound of the site and it showed infection, and i was put on 4 antibiotics.Dr.(b)(6) called the icu doctor who is in charge of the entire icu and told dr.(b)(6) that he inspected the site and it was bruised, not infected.Dr.(b)(6) told him we had the ultrasound and it was positive for infection.We decided not to go back to the surgeon as he was wrong and i could have died.I was in icu from (b)(6) 2015 and until the evening of (b)(6) 2015, and now i am in isolation with (b)(6) as well.The site is still infected and very painful and i will have a repeat ultrasound to decide whether they, a new surgeon will drain some fluid to test it.The other issue was the trial stimulator that i had for a week was a miracle i was walking on own, on swings in park, jogging a little and no pain killers.However, the permanent one is nothing like it.Very hard to charge, as hard to reach site to turn if on.Hard to charge if you lose signals and doesn't deal with the pain and neuropathy like the trial did.Very misleading.I had to make a split second decision on (b)(6) on chargeable vs nonchargeable battery.We were not told about the two and now i have the nonchargeable one and then this happens.The trial is misleading to many.After this happened, my mother researched and "it shifts" and have to get repositioned and infection rate high as well.Then i was told it could be removed, and then when i wanted it fully removed instead of repositioned the surgeon said "oh i wouldn't remove it because high risk of paralysis." wow.Currently on antibiotics, vancomycin, flagyl and cefepime.

• Brand Name: NEUROSTIMULATOR/SPINAL CORD STIMULATOR
• Type of Device: NEUROSTIMULATOR/SPINAL CORD STIMULATOR
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 5276952
• MDR Text Key: 33253478
• Report Number: MW5058387
• 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: 12/06/2015

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: No Information
• Device Model Number: 37714
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 34 YR
• Patient Weight: 127