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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION PADDLE SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1216
Device Problems Failure to Charge (1085); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Patient-Device Incompatibility (2682); Battery Problem (2885); Migration (4003)
Patient Problems Fall (1848); Undesired Nerve Stimulation (1980); Pain (1994); Burning Sensation (2146); Thrombosis/Thrombus (4440)
Event Date 07/03/2021
Event Type  Injury  
Event Description
I had a boston scientific paddle spectra wavewriter implanted on (b)(6) 2020 and i ended up having issues which resulted in me getting 3 blood clots in my left leg and 3 in my lungs. Had to get a ivc filter put it. Within a month my leads migrated and the stimulation moved to my stomach and it was so painful. The device was turned off and a revision surgery was done (b)(6) 2020 where they removed the paddle stimulator and implanted a percutaneous one. After my recovery time i tried to charge the stimulator and it wouldn't charge. I was advised that during surgery the battery was shorted out while doing the electrocautery. A revision surgery was going to have to be performed again. On (b)(6) 2021 i had my revision surgery and i was implanted with the new fda regulated stimulator, approved 12/2020 "boston scientific wavewriter alpha". The stimulator has caused me so many issues from the battery getting really hot, feeling like i'm being burned from the inside and the constant zaps i get even with it turned off. Getting zapped from something that was supposed to help with my crps i have in my right foot and leg. Sometimes it's strong enough to almost make me fall out of my wheelchair. Doctors and reps can't explain why this is happening. Fda safety report id# (b)(4).
 
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Brand NamePADDLE SPECTRA WAVEWRITER
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key12432711
MDR Text Key270322674
Report NumberMW5103736
Device Sequence Number1
Product Code LGW
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/01/2021
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received09/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSC-1216
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: 09/03/2021 Patient Sequence Number: 1
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