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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1216
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Erosion (1750); Impaired Healing (2378)
Event Date 08/03/2021
Event Type  Injury  
Manufacturer Narrative

Date of event: exact date unknown, event occurred since patients first follow up. Additional suspect medical device components involved in the event: product family: scs- linear leads, upn: m365sc2218700, model: sc-2218-70, serial: (b)(4), batch: 7079361/7079418.

 
Event Description

It was reported that the patient had an opened wound and exposing the system. The patient underwent a procedure wherein the ipg and leads were explanted. The explanted ipg and percutaneous leads will not be returned.

 
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Brand NameWAVEWRITER ALPHA 16
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 Key12380686
MDR Text Key268672577
Report Number3006630150-2021-04807
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 Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/27/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberSC-1216
Device Catalogue NumberSC-1216
Device LOT Number502840
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 Received08/06/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/21/2020
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: 08/27/2021 Patient Sequence Number: 1
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