BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1943978 · Received December 3, 2010

    Report

    Report Number
    3006630150-2010-02053
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 8, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT IS EXPERIENCING INTERMITTENT STIMULATION. ANALYSIS OF THE PT'S DATABASE REVEALED THAT THE NUMBER OF SYSTEM RESETS WAS ABNORMALLY HIGH. A REPLACEMENT OF THE IPG HAS BEEN RECOMMENDED.

    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 55 YR Required Intervention