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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION PRECISION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-9208-15
Medical Device Problem Code Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 07/24/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exact date unknown, event occurred in (b)(6) 2020.Additional suspect medical device component involved in the event: product family: scs-adapters, upn: (b)(4), model: sc-9208-15, serial: (b)(4), batch: 7028899.
 
Event or Problem Description
It was reported that the patient was not getting adequate coverage.The physician explanted the adapters and the explanted adapters will not be returned.The patient was doing well postoperatively.
 
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Brand Name
PRECISION
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 Key10586090
Report Number3006630150-2020-04460
Device Sequence Number19497134
Product Code LGW
UDI-Device Identifier08714729893271
UDI-Public08714729893271
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
P030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/25/2020
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 Date08/26/2020
Device Model NumberSC-9208-15
Device Catalogue NumberSC-9208-15
Device Lot Number5084701
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/04/2020
Initial Report FDA Received Date09/25/2020
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 Age63 YR
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