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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-1112
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pain (1994)
Date of Event 11/27/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The explanted device was not returned to bsn as it was discarded by the medical facility.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
 
Event or Problem Description
A report was received that the patient was experiencing pain at the pocket site.The patient underwent a revision procedure wherein the ipg was relocated and replaced.The patient was doing well postoperatively.
 
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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 Key7803261
Report Number3006630150-2018-02326
Device Sequence Number14075748
Product Code LGW
UDI-Device Identifier08714729837138
UDI-Public08714729837138
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/21/2018
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 Date04/01/2015
Device Model NumberSC-1112
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/03/2018
Initial Report FDA Received Date08/21/2018
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;
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