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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA®; SPINAL CORD STIMULATOR
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BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA®; SPINAL CORD STIMULATOR 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 Discomfort (2330)
Date of Event 01/17/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: model #: sc-2352-50e, serial #: (b)(4).Description: trial linear 3-4 lead, 50cm.
 
Event or Problem Description
A report was received that the trial patient had a peripheral subcutaneous lead that was burning.The patient underwent a revision procedure wherein the lead was repositioned.The patient was doing well post operatively.
 
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Brand Name
PRECISION SPECTRA®
Common Device Name
SPINAL CORD STIMULATOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key6281825
Report Number3006630150-2017-00285
Device Sequence Number16412723
Product Code LGW
UDI-Device Identifier08714729789703
UDI-Public(01)08714729789703(17)181110(10)19942856
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/17/2017
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 Date11/10/2018
Device Model NumberSC-2352-50E
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/17/2017
Initial Report FDA Received Date01/26/2017
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 Age44 YR
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