BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1369531 · Received January 30, 2009

    Report

    Report Number
    2029203-2009-00359
    Event Type
    Malfunction
    Date Received
    January 30, 2009
    Date of Event
    December 2, 2008
    Report Date
    December 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A REPORT OF UNCOMFORTABLE STIMULATION AND RESIDUAL STIMULATION WAS RECEIVED. THE PHYSICIAN DECIDED TO REPLACE THE IPG DUE TO A SUSPECTED MALFUNCTION. THE PATIENT WAS IMPLANTED WITH A NEW IPG AND IS REPORTEDLY DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MODEL: SC-2138-70| LINEAR LEAD (PHASE IIIA)