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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORP. PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTABLE FOR PAIN RELIEF Back to Search Results
Model Number SC-1132
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems AIDS, Acquired Immunodeficiency Syndrome (1684); Emotional Changes (1831); Fever (1858); Headache (1880); Hepatitis (1897); Incontinence (1928); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Paralysis (1997); Scar Tissue (2060); Scarring (2061); Tinnitus (2103); Burning Sensation (2146); Chills (2191); Anxiety (2328); Complaint, Ill-Defined (2331); Depression (2361); Impaired Healing (2378); Reaction (2414); Numbness (2415); Blood Loss (2597); No Code Available (3191)
Event Date 10/13/2016
Event Type  Injury  
Event Description
Spinal cord stimulator from boston scientific causes huge side effects like: some problems like nerve damage, removing bone with intense pain afterwards; scar tissue damage, scars, heal time , surgical pain, the intense trauma around the spine, not to mention allergic reactions; severe infections, (b)(6), (b)(6), (b)(6), contracting anything under the sun, blood loss; loss of feeling, more pain, burning in the spine, burning while charging your unit, intense pain in the site after removal, a feeling of unwell or sickness at all times; depression, not being able to take care of your family, feeling like a burden on your family, not being able to urinate, not having a menstrual cycle; the unit shocking you without cause, the unit turning on and not turning off, the feeling of being fried by the unit, change in moods; wanting to die, the unit ejecting itself from your body, not being able to perform sexually with your partners, no erections; headaches, loss of use of hands and feet, numbness in hands and feet, coldness in hands and feet, fever, squalling in ears, pain in battery are after it's out, paralyzed. Not to mention loss of wages, loss of our spouse or significant others time at work, loosing time with your children that you do not get back. This is just some of the list that the drs should be telling pts and then saying ok, do you want to try this or stay with your percocet this month and if you want to try this, we may have revise it 2-3 times and you may hate it and me when i'm done and then fight me to take it out.
 
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Brand NamePRECISION SPECTRA
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTABLE FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC CORP.
MDR Report Key8138182
MDR Text Key129752327
Report NumberMW5081864
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 Family Member or Friend
Type of Report Initial
Report Date 12/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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: 12/05/2018 Patient Sequence Number: 1
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