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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-9218-15
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Information (3190)
Date of Event 05/07/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model #: sc-9218-15 serial #: (b)(4), description: precision m8 adapter, 15cm; model #: sc-1132, serial #: (b)(4), description: precision spectra implantable pulse generator.
 
Event or Problem Description
A report was received that the patient had a suspected lead extension failure.The patient underwent an scs system replacement procedure and was doing well postoperatively.
 
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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 Key7724841
Report Number3006630150-2018-02288
Device Sequence Number732134
Product Code LGW
UDI-Device Identifier08714729888734
UDI-Public08714729888734
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/26/2018
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? Yes
Operator of Device Lay User/Patient
Device Expiration Date03/30/2017
Device Model NumberSC-9218-15
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/26/2018
Initial Report FDA Received Date07/26/2018
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 Age57 YR
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