BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2013-05222

    MDR report key: 3050043 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-05222
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED. 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 THIS PATIENT'S DEVICE WENT TO END OF LIFE (EOL) AND WAS PACING IN VVI MODE. THE PATIENT HAD BEEN LOST TO FOLLOW UP AND UPON EXAMINATION OF THE RA LEAD DURING THE REPLACEMENT PROCEDURE, IT APPEARS THE RA LEAD WAS CAPTURING THE RIGHT VENTRICLE. IT WAS SUSPECTED THAT THE RA LEAD HAD DISLODGED YEARS AGO. THE PATIENT DID NOT HAVE ANY SYMPTOMS. THE RA LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153192 DTB GUIDANT PUERTO RICO BV

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 4136| E143| 0175| 4087| 4088| 1298