BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1852439 · Received September 29, 2010

    Report

    Report Number
    3006630150-2010-01620
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    July 15, 2010
    Report Date
    August 31, 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
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A FALL INTO AN AMBULANCE DUE TO A DEGENERATIVE DISEASE, THE PATIENT'S STIMULATION CEASED. THE PATIENT WAS UNABLE TO COUPLE THE CHARGER TO THE IPG OR COMMUNICATE WITH THE IPG VIA THE REMOTE CONTROL. THE PHYSICIAN HAS DECIDED TO REPLACE THE IPG.

    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 UNK Required Intervention