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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION; SPINAL CORD STIMULATOR
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BOSTON SCIENTIFIC NEUROMODULATION PRECISION; SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-5312
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Partial thickness (Second Degree) Burn (2694)
Date of Event 09/14/2017
Type of Reportable Event Serious Injury
Event or Problem Description
A report was received that the patient's finger was blistered by the charger after charging.
 
Additional Manufacturer Narrative
Additional information was received that there was no known intervention provided for patients blistered finger.
 
Event or Problem Description
A report was received that the patient's finger was blistered by the charger after charging.
 
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Brand Name
PRECISION
Common Device Name
SPINAL CORD STIMULATOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key6908474
Report Number3006630150-2017-03805
Device Sequence Number10937576
Product Code LGW
UDI-Device Identifier08714729764465
UDI-Public08714729764465
Combination Product (Y/N)N
PMA/510(K) Number
030017
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/14/2017
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 Model NumberSC-5312
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/14/2017
Supplement Date Received by Manufacturer10/03/2017
Initial Report FDA Received Date10/02/2017
Supplement Report FDA Received Date10/19/2017
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 Age46 YR
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