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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-8216-50
Device Problems Unexpected Therapeutic Results (1631); Migration (4003)
Patient Problems Discomfort (2330); Skin Inflammation (2443); No Code Available (3191)
Event Date 12/04/2019
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-ipg-r-mri, upn: (b)(4), model: sc-1200, serial: (b)(4), batch: 363249.

 
Event Description

It was reported that the patient had some erythema at the incision site due to a reaction of the staples and sutures. Symptoms of redness and inflammation were noted. It was also stated that the patient was experiencing ineffective therapy as a result of a lead malplacement. The patient underwent a revision procedure wherein a paddle lead was replaced by 2 linear leads to provide larger coverage. The explanted devices was not returned. No further information has been obtained despite good faith efforts.

 
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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
road 698, lot no. 12
dorado PR 00646 -260
00646-2602
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key10332411
MDR Text Key200612698
Report Number3006630150-2020-03114
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 07/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/28/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/12/2020
Device MODEL NumberSC-8216-50
Device Catalogue NumberSC-8216-50
Device LOT Number7037078
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 Received07/01/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/15/2018
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: 07/28/2020 Patient Sequence Number: 1
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