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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-5312
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code Burn(s) (1757)
Date of Event 09/21/2019
Type of Reportable Event Serious Injury
Event or Problem Description
A report was received that the patient was burned twice by the external charger.Blisters around the affected area was noted.The physician confirmed that no further medical intervention was required.The patient was doing well.
 
Event or Problem Description
A report was received that the patient was burned twice by the external charger.Blisters around the affected area was noted.The physician confirmed that no further medical intervention was required.The patient was doing well.
 
Additional Manufacturer Narrative
Sc-5312, sn: (b)(6).Device evaluation indicated that the charger passed all the required tests and exhibited normal device characteristics.
 
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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 Key9450452
Report Number3006630150-2019-07242
Device Sequence Number2089985
Product Code LGW
UDI-Device Identifier08714729764465
UDI-Public08714729764465
Combination Product (Y/N)N
PMA/510(K) Number
P030017
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) 03/13/2020
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 Model NumberSC-5312
Device Catalogue NumberSC-5312
Device Lot Number18560820
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2019
Initial Date Received by Manufacturer 11/21/2019
Supplement Date Received by Manufacturer03/03/2020
Initial Report FDA Received Date12/11/2019
Supplement Report FDA Received Date03/13/2020
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 Age44 YR
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