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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION ARTISAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-8120-70
Device Problem Migration (4003)
Patient Problems Irritation (1941); Pain (1994); Discomfort (2330); No Code Available (3191)
Event Date 08/22/2019
Event Type  Injury  
Manufacturer Narrative

Exact date unknown, event occurred in (b)(6) 2019. Additional suspect medical device components involved in the event: product family: scs-extension, upn: (b)(4), model: sc-3138-35, serial:(b)(4), batch: 18409863/18952672. Product family: scs-lead fixation: upn: (b)(4), model: sc-4316, batch: 14302394.

 
Event Description

It was reported that the patients lead migrated and the patients lead extensions position were causing pain and irritation under the skin. The patient underwent a revision procedure wherein the lead extensions, clik anchor and lead were explanted and replaced. The patient was doing well postoperatively. The explanted devices were disposed.

 
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Brand NameARTISAN
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
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key10950361
MDR Text Key219850053
Report Number3006630150-2020-06024
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 12/04/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/05/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2009
Device MODEL NumberSC-8120-70
Device Catalogue NumberSC-8120-70
Device LOT Number214944A
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 Received11/17/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/31/2008
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: 12/05/2020 Patient Sequence Number: 1
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