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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR ST; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION LINEAR ST; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2218-70E
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Dizziness (2194)
Date of Event 04/17/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The explanted device was not returned to bsn as it was kept by the medical facility.
 
Event or Problem Description
A report was received that following a trial procedure, the patient was getting light headed.The physician believed that the lead was causing pressure which caused a decreased ability for blood flow.The patient underwent a lead pull procedure and was doing well postoperatively.
 
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Brand Name
LINEAR ST
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 Key8582664
Report Number3006630150-2019-02070
Device Sequence Number1644318
Product Code LGW
UDI-Device Identifier08714729820741
UDI-Public08714729820741
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
P030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/06/2019
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 Date12/18/2019
Device Model NumberSC-2218-70E
Device Catalogue NumberSC-2218-70E
Device Lot Number5016105
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/17/2019
Initial Report FDA Received Date05/06/2019
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 Age28 YR
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