BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1172081 · Received September 23, 2008

    Report

    Report Number
    2029203-2008-00651
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORTION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THAT A PATIENT WAS EXPERIENCING SHORTNESS OF BREATH WITH THE STIMULATION ON. THE PATIENT'S STIMULATION WAS TURNED OFF AND THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM. NO TREATMENT WAS PROVIDED AT THE EMERGENCY ROOM. A REPROGRAMMING OF THE IMPLANT WAS PERFORMED AND THAT RESOLVED THE PATIENT'S UNWANTED STIMULATION. THE PATIENT IS REPORTEDLY DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ST LINEAR LEAD