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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
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  No Answer Provided  
Event Description
Spinal stimulator sticking out from skin. (b)(6) back.
 
Event Description
Additional info received from reporter on 3/13/2019 for mw5084805: reporter states that the stimulator is still implanted and the doctors are not trying to remove it. He wants the fda to get involved in order to get it removed.
 
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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 Key8409787
MDR Text Key138934399
Report NumberMW5084805
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,Followup
Report Date 03/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2019
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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: 03/11/2019 Patient Sequence Number: 1
Treatment
GOODY'S POWDER
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