• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC PRECISION SPECTRA 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 Muscle Weakness (1967); Malaise (2359); Numbness (2415); Ambulation Difficulties (2544); Cognitive Changes (2551); Electric Shock (2554); Swelling/ Edema (4577)
Event Type  Injury  
Event Description

On (b)(6) 2016 i had surgery to implant boston scientific spinal cord stimulator, right away i noticed sporadic shocking jolts in various spots along my spine but mostly about my bra strap. Within 3-4 months i had burning too in the same area but would travel up and down spine. I mention this to dr. North a few times, he would say we need to get a ct scan but would not follow through with scheduling. I have recorded conversations for most of my visits. After a year and a half i turned the thing off!! i had told dr. (b)(6) and his assistants of this and was told three times i needed to have it reprogrammed. This was after i told them i could not take the sensation of the scs in my legs it made them weak and was reprogrammed with high tensity program. The high tensity was better in the fact that i didn't feel the constant vibration but after a few months i was sick all the time, my legs were numb i could hardly walk unassisted, had no desire to have sex with my husband, couldn't take care of my granddaughter that we have custody or get out of the house, among other things. Trying have room to fit most on here skipping forward. After two and a half years of this i told them i wanted it out. My scs was explanted on (b)(6) 2018 and an mri was done in (b)(6) when dr. (b)(6) office would finally see me, the first thing i was told, i have myelomalacia of cervical cord and lumbar, also was told my spinal cord is compressed narrowing. I was sent to a specialist at novant health brain and spine surgery and was told i had an injury and needed surgery right away, after second opinion i was told i had six month before i would be paraplegic. I left out a ct scan was finally done in 2017 showing i had arthritis in my cervical spine. I had 3-4 levels operated on. The conclusion in my mri report states that the history of the scs may have caused the damages/injuries to my spine. Due to me being on max dose of lyrica i lose train of thought and can not think of every detail at this time. I have filled this form out before but could not find after returning to website, i have no idea what i did wrong. I have mri reports, recordings etc. I have proof that dr. (b)(6) or staff went into my online patient account and changed my diagnosis on two occasions. I requested my scs and leads but only given the battery after explant. I can't type anymore now, my hands are swollen and i can't think anymore. Fda safety report id# (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBOSTON SCIENTIFIC PRECISION SPECTRA
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key11874900
MDR Text Key253043930
Report NumberMW5101523
Device Sequence Number1
Product Code LGW
Combination Product (Y/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 05/21/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/24/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberSC-1132
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: 05/24/2021 Patient Sequence Number: 1
-
-