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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1432
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Sleep Dysfunction (2517); Insufficient Information (4580)
Event Date 03/18/2021
Event Type  Injury  
Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event. Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: (b)(4), model: sc-2317-70, serial: (b)(4), batch: (b)(4). Product family: scs-lead fixation, upn: (b)(4), model: sc-4318, batch: 22659869.

 
Event Description

It was reported that the patient had significant weight and was experiencing metallic taste in his mouth, dry eyes, and difficulties with sleeping following an ipg upgrade. It was also stated the patient thought that the ipg wad leaking inside the body. The physician believed that the patients symptoms were not device related and the cause were unknown. The patient underwent a procedure wherein all device components were explanted and that the patient was doing well postoperatively. The explanted device components will be returned.

 
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Brand NameWAVEWRITER ALPHA PRIME
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 Key11967295
MDR Text Key255178096
Report Number3006630150-2021-02775
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,Followup
Report Date 08/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/09/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberSC-1432
Device Catalogue NumberSC-1432
Device LOT Number201553
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/24/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/02/2020
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: 06/09/2021 Patient Sequence Number: 1
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