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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 Abscess (1690); Unspecified Infection (1930); Undesired Nerve Stimulation (1980)
Event Date 06/10/2021
Event Type  Injury  
Manufacturer Narrative

Exact date unknown, event occurred a couple days after implant. Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2366500, model: sc-2366-50, serial: (b)(4), batch: 7073254/7073304.

 
Event Description

It was reported that the patient had a suspected abscess around the ipg site which could be contributing to pneumonia-like symptoms. The physician assessed that the patient had an infection. It was also noted that the patient was experiencing undesired sensation even if stimulation was turned off. The patient was hospitalized and was provided medical treatment. The patient was doing well.

 
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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 Key12148843
MDR Text Key260929070
Report Number3006630150-2021-03704
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 07/12/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/12/2021
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 Number511395
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 Received06/21/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/11/2021
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: 07/12/2021 Patient Sequence Number: 1
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