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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 Charging Problem (2892); Positioning Problem (3009); Wireless Communication Problem (3283)
Patient Problems Nerve Damage (1979); Pain (1994)
Event Date 08/12/2019
Event Type  Injury  
Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: (b)(4), model: sc-2218-50, serial: (b)(4), batch: 5039093/5039237.

 
Event Description

It was reported that the patient experienced pain at the incision site from the revision procedure wherein the ipg was relocated (mfr report number 3006630150-2019-04668) and the physician believed there might be some nerve damage from the surgery. It was also reported that the patient had difficulty charging the ipg and connecting to the remote control. Database analysis of the battery discharge was observed and revealed no anomalies. The charge profile showed signs of poor charger to ipg coupling and the charger thermistor triggering often which can delay charging times. All components were explanted and discarded.

 
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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 Key11580720
MDR Text Key242661186
Report Number3006630150-2021-01255
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,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/29/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/29/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/08/2020
Device MODEL NumberSC-1160
Device Catalogue NumberSC-1160
Device LOT Number344535
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 Received03/09/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/10/2018
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: 03/29/2021 Patient Sequence Number: 1
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