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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-1010C
Medical Device Problem Codes Unexpected Therapeutic Results (1631); Charging Problem (2892)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 03/28/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The explanted ipg was not returned to bsn as it was kept by the medical facility.A review of the manufacturing documentation for the ipg revealed that no anomalies or deviations potentially relate to the event occurred during manufacturing.
 
Event or Problem Description
A report was received that the patient was experiencing inadequate stimulation and ipg frequent charging.No device malfunction was suspected.The patient underwent an ipg replacement procedure and was doing well postoperatively.
 
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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 Key8697465
Report Number3006630150-2019-02777
Device Sequence Number14028271
Product Code LGW
UDI-Device Identifier08714729821519
UDI-Public08714729821519
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/13/2019
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 Date06/17/2017
Device Model NumberSC-1010C
Device Catalogue NumberSC-1010C
Device Lot Number250570
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/24/2019
Initial Report FDA Received Date06/13/2019
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 Age73 YR
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