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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINAL CORD STIMULATOR; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
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SPINAL CORD STIMULATOR; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)
Event Date 02/20/2020
Event Type  Injury  
Event Description
Pt had a spinal cord stimulator put in and has had increased back pain since the surgery, unsure if it is flares or from the procedure.
 
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Brand Name
SPINAL CORD STIMULATOR
Type of Device
STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
MDR Report Key10158079
MDR Text Key195442223
Report NumberMW5095014
Device Sequence Number1
Product Code GZB
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age64 YR
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