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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-3400-30
Medical Device Problem Code High impedance (1291)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/06/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model#: sc-3400-30, serial #: (b)(4), description: infinion splitter 2x8 kit (30 cm).The explanted devices were not returned to bsn as they were discarded by the medical facility.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.
 
Event or Problem Description
A report was received that the splitter was causing high impedance.The patient undergo an explant procedure.The patient 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 Key7469612
Report Number3006630150-2018-01414
Device Sequence Number1051994
Product Code LGW
UDI-Device Identifier08714729797838
UDI-Public08714729797838
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date01/30/2015
Device Model NumberSC-3400-30
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/06/2017
Initial Report FDA Received Date04/27/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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