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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONICS IMPLANTED SPINAL STIMULATORS

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MEDTRONICS IMPLANTED SPINAL STIMULATORS Back to Search Results
Model Number 37713
Device Problems Premature Discharge of Battery (1057); Break (1069); Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892); Communication or Transmission Problem (2896)
Patient Problems Arthritis (1723); Chest Pain (1776); Pain (1994); Increased Sensitivity (2065); Skin Discoloration (2074); Burning Sensation (2146); Cramp(s) (2193); Discomfort (2330); Inadequate Pain Relief (2388); Neck Pain (2433); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Electric Shock (2554)
Event Date 03/03/2008
Event Type  Injury  
Event Description
I think i was the first person to have a double implanted medtronic units installed in the cervical, thoracic, and lumbar spine in my body.As the medtronic reps had told me this anyway and were consulting on how they were going to power and wire all three lead tips.This device has malfunctioned in my body causing severe mid thoracic spurring and arthritis resulting in pain in my neck with narrowing of spinal canal where lead tips were placed, mid thoracic pain is the worst with charley horse pains around shoulder blades, bad rib pain, and lower back constant.I'm unable to have any quality of life due to the severe pain with every step, or movement at all really.This medtronic device has caused me more pain and discomfort than before it was installed.This is making life unbearable to live with, and my doctor, dr (b)(6), has decided to remove these devices.They are as big as cigarette packs, one located under my left arm pit, and the other one is above my right lower hip sticking out considerably and noticeable on my ribcage.They suspect lead migration, broken wires, this lead tip from t7-t9 in the thoracic spine has caused severe spurring and arthritis in the area of the incision.This is only 1 incision out of 4 incisions and not all problems listed.Unwanted shocking in upper stimulator with movement of head and need to sleep with head in a different and particular way to ease unwanted shocking.This problem has existed since the implants were installed (both of them).The upper they adjusted several times and is in my paperwork, and in the end said that was the best it was going to get by the medtronic rep himself on several occasions, and they are aware the lower device has quit over 3-4 years ago.We met with another medtronic rep and he verified that the lower unit was not working and could not communicate with the implanted unit to adjust or do anything at all to adjust or fix in any way, lower implant was just done working.So i have a device in my body causing me severe pain and neither device has ever worked properly and lower is not working at all and feels like it has attached to something in my body, it has moved up on to the bottom of rib cage, 1" from center of spine compressing against my rib cage and spinal cord, causing severe pain with any movement.Lead tips are also causing narrowing of spinal canal in cervical, thoracic spine as also stated in my last myelogram about a month ago.Out of characters! while the lower unit did only work about a year or less, when it did work.I was told it would need to be charged every 4-5 days for 1-3 hours, well the position of the lower being up on my rib cage and tilted at a pretty big angle, the 2" velcro belt and suitcase, the belt was carried in, has a 5" or so disk that has to be positioned over the lower stimulator battery pack and seemed to have to be very tight to get the device to charge and was just so uncomfortable, it was torture almost and had to be done every 2-3 days 5-6 hours to get charged and would just cut into my back, not literally but would leave very bright blood red mark that i also took pictures of and reported and showed them to dr (b)(6), half of the battery life i thought i was going to get, and the suitcase to carry around.I feel like i was very misled to the benefits i received in comparison to the results they were selling and i would have loved to see a film of this surgery or had more information as i had no idea of the incision on the back of my neck is tremendous, or the one on the thoracic spine would cause so much damage where the lead tips were placed, worst decision i have ever made in my life.Burning like fire at lower battery pack when i would charge it for 5-6 hours, i was really kind of glad when it quit working, because i would no longer have to go through the torture of just charging this lower unit 3 times a week 5-6 hours at a time, just miserable (upper battery was not chargeable).They are now removing upper cervical, mid thoracic, and lumbar lead tips, wires, and both battery packs as they figured out they were all wired together and we could not just remove one, as i told him i was very afraid.The upper incision is from my skull down to top of my shoulder blades and the left half of my face went hyper sensitive for several years, very, very bad and is down to tolerable, although i still can't wear a hat, as i did all my life as a truck driver, and now i have to have them both cut out, very soon! surgery is scheduled to remove them on this coming monday, (b)(6) 2014 i am scared to death, three 3" plus inch cuts on my back and cutting.Medtronic rep met with me and verified lower unit quit, by trying to get his master controller to get it to work and could not, so it should have already been reported as defective by medtronics several years ago.Unit number are medtronics stimulation system / implant date - (b)(6) 2008, model number 37713 with serial number (b)(4) and model number 37702 with serial number (b)(4) both were implanted same day.Emergency physician listed on implant device identification cards.I am sure there are more symptoms and problems i have not said as i am hurting very bad as i write this.Thank you, for your time, god bless and protect, (b)(6).
 
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Brand Name
IMPLANTED SPINAL STIMULATORS
Type of Device
STIMULATOR
Manufacturer (Section D)
MEDTRONICS
MDR Report Key3896139
MDR Text Key4543951
Report NumberMW5036804
Device Sequence Number1
Product Code GZB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/19/2014
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number37713
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/20/2014
Patient Sequence Number1
Patient Age35 YR
Patient Weight88
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