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Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Discomfort (2330)
Event Date 02/08/2011
Event Type  Injury  
Event Description
On (b)(6) 2011, i had a medtronic interstim placed in my right hip in an effort to resolve bladder incontinency issues. I experienced significant pain during the first 5 days after surgery. I returned to my doctor (b)(6), due to the pain and debilitation from surgery. She suggested, it would take time to return to normal and told me not to return to work for two weeks and return to her at that time for a checkup. During this two week period, i experienced shooting, shocking pain down my right leg, "buzzing" pain in my tailbone, shooting, shocking pain up into my right shoulder, and never-ending pain at the two surgical sites. I could not lay on my back or my right side. I could not sit back in a chair or drive a car. I could not walk or stand for more than a few minutes. All i could do was lay on my left side. I was totally debilitated as a result of the surgery and implantation of this device. During these two weeks, i adjusted the device multiple times using my remote adjustment control. I never received relief from the zapping and painful symptoms on any of the device settings. Finally two weeks after surgery (b)(6), i turned the device off as i could not stand the painful side effects of the stimulation. When i returned to the doctor (b)(6), i was not better, but worse. She ordered a cat scan to see if there was an infection. The results were negative. She told me to remain off work an additional week. At the follow up appointment (b)(6), (24 days post surgery) she ran extensive blood tests to see if i had an infection as i was not recovering but continuing to be in extreme pain. She also removed the sutures from the secondary (mid-spine) surgery site during this visit. The blood test results were negative. I went back to work half days the week of (b)(6) but my pain and discomfort continued to rise. I still could not drive due to pain and inability to sit back in the driver's seat so my husband was taking me to work. On wednesday (b)(6), i called my doctor at night as i was in overwhelming pain at the implant site. I saw her the next day (b)(6) and she hospitalized me as she saw an infection in my secondary surgery site, the one where sutures were removed the previous friday. I was hospitalized for three days during which time i received iv antibiotic therapy, morphine pump pain management and on (b)(6) surgery to remove the interstim from my body. Since that time i have been in constant pain at the implant site and in the tailbone area. I have shocking sensations going through my right hip. I still cannot comfortably lay on my right side or back. The entire right hip is very tender and does not tolerate sitting for long periods of time, exercise, or constriction such as wearing a pair of jeans or pants. I still have the incontinence issue but would never consider interstim as an alternative to alleviate those symptoms. This is a destructive device that is harming many women. I never had relief from my incontinence problems when the device was in my body and turned on. Why do you not take it off the market? why do you not stop medtronic from selling it? why do you not stop doctors from butchering women by implanting it? why not some kind of info to tell women the real story of this device, not the medtronic story of the device? event abated after use: no.
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Type of DeviceINTERSTIM
Manufacturer (Section D)
MDR Report Key2084979
MDR Text Key1987909
Report NumberMW5020534
Device Sequence Number1
Product Code EZW
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/05/2011
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2011
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/05/2011 Patient Sequence Number: 1