BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2013-01303

    MDR report key: 2920890 · Received January 17, 2013

    Report

    Report Number
    2124215-2013-01303
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 14, 2012
    Report Date
    March 20, 2013
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ANY ADDITIONAL INFORMATION ON THE INCIDENT AND THE PRODUCT INVOLVED WERE UNSUCCESSFUL. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE EXPERIENCED AN ADVERSE EVENT DURING A NORMAL DEVICE FOLLOW UP VISIT. THE PATIENT WAS SUCCESSFULLY TREATED WITHOUT ANY OTHER ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. THE MODEL AND SERIAL NUMBER OF THE DEVICE IS CURRENTLY UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS OCCURRENCE IS CURRENTLY BEING MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26772 LWS GUIDANT PUERTO RICO BV TACHY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R