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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR 3-4; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION LINEAR 3-4; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2352-50E
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Staphylococcus Aureus (2058)
Date of Event 05/19/2014
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exact date unknown, event occurred during the trial period last 2014.Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: (b)(4), model: sc-2352-50e, serial: (b)(4), batch: 16707328.Explant date: ni.
 
Event or Problem Description
It was reported that the patient had a staphylococcus infection during the trial procedure.The patient underwent a lead pull procedure.
 
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Brand Name
LINEAR 3-4
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 Key10576437
Report Number3006630150-2020-04407
Device Sequence Number19152975
Product Code LGW
UDI-Device Identifier08714729789703
UDI-Public08714729789703
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
P030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date02/12/2016
Device Model NumberSC-2352-50E
Device Catalogue NumberSC-2352-50E
Device Lot Number16707328
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/02/2020
Initial Report FDA Received Date09/23/2020
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 Age49 YR
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