BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1971617 · Received January 25, 2011

    Report

    Report Number
    3006630150-2011-00107
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF MFG DOCUMENTATION OF THE EXPLANTED DEVICES FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MFG. A REVIEW OF STERILIZATION RECORDS OF THE EXPLANTED DEVICES FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT THAT A PT'S PRECISION SYSTEM WAS EXPLANTED DUE TO SKIN EROSION WAS RECEIVED. THE PT HAD LOST AND GAINED WEIGHT MULTIPLE TIMES, MAKING THE STIMULATION ERODE THROUGH THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ARTISAN 2X8 PADDLE LEAD(W/SLOTTED ELECTRODES),70CM| MODEL#SC-8120-70, (B)(4)