BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1850885 · Received September 28, 2010

    Report

    Report Number
    3006630150-2010-01634
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT THE PT'S PRECISION SYSTEM WAS EXPLANTED DUE TO DIFFICULTY CHARGING. THE PHYSICIAN ALSO FELT THE PT MIGHT HAVE NON-DEVICE RELATED BACK ISSUES AND AN MRI WAS NEEDED.

    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 49 YR Required Intervention ARTISAN 2X8 PADDLE LEAD(W/SLOTTED ELECTRODES) 70CM| MODEL #: SC-8120-70,| SERIAL #: (B)(4)