BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1970287 · Received January 14, 2011

    Report

    Report Number
    3006630150-2011-00047
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    October 28, 2010
    Report Date
    October 28, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS A DUPLICATE OF REPORT NO. 3006630150-2011-00042. THE REPORT INCLUDES DEVICE ANALYSIS ALSO. THERE IS NO NEW INFORMATION REGARDING THE EVENT SINCE THAT REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT'S IPG WAS REPLACED DUE TO DISCOMFORT AT THE POCKET SITE AND INTERMITTENT STIMULATION. ANALYSIS PERFORMED ON THE IPG DATABASE COULD NOT CONFIRM ANY ABNORMALITY. THE PT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS REPLACED DUE TO DISCOMFORT AT THE POCKET SITE AND INTERMITTENT STIMULATION. ANALYSIS PERFORMED ON THE IPG DATABASE COULD NOT CONFIRM ANY ABNORMALITY. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention