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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPINAL STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC CORPORATION SPINAL STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1110-02
Device Problems Material Protrusion/Extrusion (2979); Therapeutic or Diagnostic Output Failure (3023); Appropriate Term/Code Not Available (3191)
Patient Problems Failure of Implant (1924); Pain (1994); Therapeutic Response, Decreased (2271)
Event Date 02/13/2019
Event Type  Injury  
Event Description

Stimulator poking my skin and is like knife cutting my back. Must have removed. Also, just learned mfr agent used old model and prevents me from having mris needed. Stimulator implanted (b)(6) 2016. Told it was smallest and most modern version. No warning that i could not have medically needed mri or ultrasound treatments. Malfunctioned on (b)(6) 2019 moved and is cutting through the skin in my back. Went to surgeon for removal. States the metal based leads are fused to my spinal bone and must cut me. Boston scientific lied about the unit. I agreed to have it installed because i was told there would be no side effects. Refused mri when i have a shoulder injury left me months in excruciating pain. Not being able to see the condition of degenerative disc disease (the purpose of the stimulator installed). Now the unit moved and cutting back and malfunctioned. Surgeon states he must cut me in three places including bone l7 and l8 spine (discs were perfect not defective but for stimulator) the reason i had it installed was to prevent. The mfr sent a rep to inform me about the benefits of the stimulator. He told me i was getting the best and latest model with no restrictions. I learned when i fell and hurt my shoulder that the unit i have is not compatible with mri technology. Would not have installed because i have lung disease and joint arthritis, so i need mri to treat my conditions. Also, the unit moved and is poking through my back like a knife. Doesn't function and the leads are fused to my spinal bone. I installed to prevent having my bone cut and now must cut to remove. The removal is invasive and not disclosed as a future problem. Also, i reported this (b)(6) 2018 and it was not submitted to fda.

 
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Brand NameSPINAL STIMULATOR
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key8873914
MDR Text Key153806543
Report NumberMW5088871
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 08/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberSC-1110-02
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/07/2019 Patient Sequence Number: 1
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