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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION PRECISION MONTAGE MRI SPINAL CORD STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1200
Device Problem Material Protrusion/Extrusion (2979)
Patient Problems Muscle Spasm(s) (1966); Pain (1994)
Event Date 12/13/2018
Event Type  Injury  
Event Description

In (b)(6) 2018 dr. Failed to tell me i had a pinched nerve in neck. Suggested spinal cord stimulator (boston scientific) placed (b)(6) 2018. Leads caused muscle spasms and severe pain on left side between spine and shoulder blade, and leads started protruding from spine, causing severe pain. Begged dr to remove. He said he would fix. Revision done (b)(6) 2019. Muscle spasms increased along with spine pain. Informed dr. At least every 2 weeks up to (b)(6) 2019. He prescribed pain meds and muscle relaxers, never investigating the issue. I sought 2nd opinion. Surgeon informed me of pinched nerve seen in original films and that i should have never gotten the spinal cord stimulator. I have had surgery from other surgeons to repair neck and remove spinal cord stimulator. I have since been declared disabled and still in severe pain from initial placement of stimulator. I have filed a complaint with the medical board of (b)(6). Fda safety report id #: (b)(4).

 
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Brand NamePRECISION MONTAGE MRI SPINAL CORD STIMULATOR
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key10390304
MDR Text Key202613849
Report NumberMW5095987
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 08/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSC-1200
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: 08/10/2020 Patient Sequence Number: 1
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