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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-9218-15
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Erosion (1750); Pain (1994)
Date of Event 12/05/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: sc-9218-15, serial number: (b)(4), batch/lot number: 20062160, model/catalog description: precision m8 adapter 15cm.
 
Event or Problem Description
A report was received that the patients leads were tearing the flesh when bending over.It was noted that the leads were causing pain being in the surface of the skin.It was unknown if there was skin breakage.
 
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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 Key8191984
Report Number3006630150-2018-62446
Device Sequence Number1900940
Product Code LGW
UDI-Device Identifier08714729888734
UDI-Public08714729888734
Combination Product (Y/N)N
PMA/510(K) Number
P030017
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) 12/21/2018
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? No
Operator of Device Lay User/Patient
Device Expiration Date12/13/2018
Device Model NumberSC-9218-15
Device Catalogue NumberSC-9218-15
Device Lot Number20062160
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/05/2018
Initial Report FDA Received Date12/21/2018
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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