BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1933738 · Received December 16, 2010

    Report

    Report Number
    3006630150-2010-02163
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT IS HAVING TO CHARGE MORE OFTEN THAN USUAL AND IS GETTING A JOLT WHEN THE DEVICE IS TURNED ON OR OFF. THE PHYSICIAN SUSPECTS THE DEVICE MAY BE MALFUNCTIONING AND PLANS ON EXPLANTING THE PT'S SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention