BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1052586 · Received May 22, 2008

    Report

    Report Number
    2029203-2008-00330
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 30, 2008
    Report Date
    April 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED COMMUNICATION AND CHARGING ISSUES BETWEEN THE IMPLANT AND THE EXTERNAL EQUIPMENT. A BOSTON SCIENTIFIC REP PERFORMED DEVICE EVAL. THE PROBLEM WAS CONFIRMED. EXPLANT SURGERY HAS BEEN RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORP SC-1100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1