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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-1112
Medical Device Problem Code Charging Problem (2892)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 10/05/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.
 
Event or Problem Description
It was reported that the patient was having charging difficulties.The underwent an ipg explant procedure.Explanted ipg will not be returned.
 
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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 Key10850348
Report Number3006630150-2020-05587
Device Sequence Number3189945
Product Code LGW
UDI-Device Identifier08714729837138
UDI-Public08714729837138
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
P030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/17/2020
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? Yes
Operator of Device Lay User/Patient
Device Expiration Date04/30/2015
Device Model NumberSC-1112
Device Catalogue NumberSC-1112
Device Lot Number16043441
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/28/2020
Initial Report FDA Received Date11/17/2020
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 Age45 YR
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