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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1232
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Unspecified Infection (1930)
Event Date 07/28/2021
Event Type  Injury  
Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: scs-paddle leads, upn: m365sc8336500, model: sc-8336-50, serial: (b)(4), batch: 7073503.

 
Event Description

It was reported that the patient had an infection at the pocket site. It was also noted that the incision opened up making the ipg visible. Symptoms of infection were fever and tender to touch or charge. The patient was prescribed with antibiotics and underwent a system explant procedure.

 
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Brand NameWAVEWRITER ALPHA
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 Key12365803
MDR Text Key268074559
Report Number3006630150-2021-04748
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 08/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/25/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberSC-1232
Device Catalogue NumberSC-1232
Device LOT Number502809
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 Received08/05/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/07/2021
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: 08/25/2021 Patient Sequence Number: 1
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