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

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).

• Brand Name: PADDLE SPECTRA WAVEWRITER
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 12432711
• MDR Text Key: 270322674
• Report Number: MW5103736
• Device Sequence Number: 1
• Product Code: LGW
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SC-1216
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 42 MO
• Patient Weight: 77