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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)
Event Date 07/17/2021
Event Type  Injury  
Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: scs-linear leads-mri, upn: m365sc2408560, model: sc-2408-56, serial: (b)(4), batch: 7073317/7073452. Product family: scs-lead fixation-mri, upn: m365sc43190, model: sc-4319, serial: n/a, batch: 24856298.

 
Event Description

It was reported that the patient developed an infection at the ipg site. Symptom of abscess at the ipg site was noted. The physician believed that the infection was not device related. No device malfunction was suspected. The patient underwent a full spinal cord stimulator (scs) explant procedure and was doing well post-operatively. The explanted devices will not be returned. No further information has been obtained despite good faith efforts.

 
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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 Key12302326
MDR Text Key265853873
Report Number3006630150-2021-04423
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 08/10/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/10/2021
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 Number511602
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 Received07/20/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/17/2021
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: 08/10/2021 Patient Sequence Number: 1
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