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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-5312
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Burn(s) (1757); Burning Sensation (2146); Discomfort (2330)
Date of Event 09/06/2017
Type of Reportable Event Serious Injury
Event or Problem Description
A report was received that the patient was getting some like of a burn when charging as the ipg was getting hot.
 
Additional Manufacturer Narrative
Additional information was received that there will be no further course of action at this time.
 
Event or Problem Description
A report was received that the patient experienced excessive sweating throughout her body, discomfort, and the sensation of burning due to the ipg feeling hot while charging.
 
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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 Key6892160
Report Number3006630150-2017-03746
Device Sequence Number19020396
Product Code LGW
UDI-Device Identifier08714729764465
UDI-Public08714729764465
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
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) 09/06/2017
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 09/06/2017
Supplement Date Received by Manufacturer10/10/2017
Initial Report FDA Received Date09/25/2017
Supplement Report FDA Received Date11/01/2017
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 Age69 YR
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