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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORP. SPINAL-CORD STIMULATOR STIMULATOR, SPINAL-CORD TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1132
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Headache (1880); Nerve Damage (1979); Swelling (2091); Blurred Vision (2137); Burning Sensation (2146); Inadequate Pain Relief (2388); Sleep Dysfunction (2517); Alteration In Body Temperature (2682); No Code Available (3191)
Event Date 12/28/2015
Event Type  Injury  
Event Description
Patient called to report adverse events involving her spinal-cord stimulator. Patient stated that since she had the device implanted on (b)(6) 2015, she has never felt any relief, she¿s only kept getting worse. In (b)(6) of 2016, patient said she had more leads implanted in her neck, but they only caused her more problems. In (b)(6) of 2017, patient said she felt excessive heat inside of her body, like she was on fire. Patient said she could barely walk or stand and her leg was purple and was told she had crp (complex regional pain syndrome). Patient stated her elbows are raw, she has a constant burning feeling but feels freezing cold on the outside. Patient also said she has sciatic nerve pain, problems sleeping, blurry vision, swollen eyes, loss of balance, headaches, and can no longer work. Patient would like the device removed, but her current physician refuses to remove the device. Patient stated she wants her quality of life back.
 
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Brand NameSPINAL-CORD STIMULATOR
Type of DeviceSTIMULATOR, SPINAL-CORD TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC CORP.
300 boston scientific way
marlborough MA 01752
MDR Report Key8115604
MDR Text Key129034390
Report NumberMW5081708
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 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSC-1132
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: 11/28/2018 Patient Sequence Number: 1
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