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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 Discomfort (2330); No Code Available (3191)
Date of Event 01/13/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: sc-3138-35, serial number: (b)(4), batch/lot number: 7003606, model/catalog description: lead extension kit 35 cm.
 
Event or Problem Description
A report was received that the patient was experiencing discomfort at the extension pocket site.The patient underwent a revision procedure and was doing well postoperatively.
 
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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 Key9667250
Report Number3006630150-2020-00364
Device Sequence Number501705
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
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/04/2020
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 Date01/13/2020
Device Model NumberSC-3138-35
Device Catalogue NumberSC-3138-35
Device Lot Number5020895
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/14/2020
Initial Report FDA Received Date02/04/2020
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 Age61 YR
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