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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-3138-35
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Erosion (1750); Pain (1994)
Date of Event 05/07/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.Additional suspect medical device component involved in the event: product family: scs-extension, upn: (b)(4), model: sc-3138-35, serial: (b)(4), batch: 7023161.
 
Event or Problem Description
It was reported that the patients lead extension site protruded and caused pain.There was no skin breakage.The lead extensions were explanted and discarded.
 
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Brand Name
NA
Common Device Name
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key11580723
Report Number3006630150-2021-01256
Device Sequence Number4781478
Product Code LGW
UDI-Device Identifier08714729760559
UDI-Public08714729760559
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
P030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Expiration Date02/13/2020
Device Model NumberSC-3138-35
Device Catalogue NumberSC-3138-35
Device Lot Number7008680
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/09/2021
Initial Report FDA Received Date03/29/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age67 YR
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