BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS

    MDR report key: 5172518 · Received October 24, 2015

    Report

    Report Number
    2124215-2015-11389
    Event Type
    Injury
    Date Received
    October 24, 2015
    Date of Event
    July 7, 2015
    Report Date
    August 6, 2015
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    JSK
    PMA / PMN Number
    K822458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PRODUCTS WERE DISCARDED AT THE HOSPITAL. 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 SURGICAL WOUND AT THE DEVICE POCKET DID NOT CLOSE PROPERLY AND THE DEVICE WAS EXPOSED. THE SYSTEM WAS EXPLANTED DUE TO A HIGH RISK OF INFECTION, AND A NEW SYSTEM WAS IMPLANTED ON THE PATIENT铠RIGHT SIDE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704782 TRANSVENOUS IMPLANTABLE LEAD JSK GUIDANT PUERTO RICO BV 4160

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R