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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1160
Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Inflammation (1932); Muscle Spasm(s) (1966); Pain (1994); Paralysis (1997); Injury (2348); No Code Available (3191)
Event Date 05/15/2020
Event Type  Injury  
Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: (b)(4), model: sc-2158-70, serial: (b)(4), batch: 15266123 and 15541852.

 
Event Description

It was reported that the patient experienced multiple severe medical problems including full body paralysis. The patient reported that during an appointment at the physician office the physician assistant, in an effort to troubleshoot the device, heightened the frequency and the patient experienced a hairline broken bone at the spinal cord. The physician scheduled the patient for a intralaminar cervical epidural injection. While waiting for the scheduled injection, the patient reports three months of severe paralyzed body condition and that the pain was so severe the patient could not move. Once the cervical epidural injection was completed, the patient developed severe side effects including cramps on the left side of the body and pain at the implant site. The patient indicates that the device is not working and the device is moving close to the spinal cord causing a problem with the nerve and inflammation.

 
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Brand NameSPECTRA WAVEWRITER
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key10143673
MDR Text Key194812984
Report Number3006630150-2020-02431
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/15/2020
Device MODEL NumberSC-1160
Device Catalogue NumberSC-1160
Device LOT Number334036
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/16/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/11/2020 Patient Sequence Number: 1
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