BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2013-01611

    MDR report key: 3043273 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01611
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    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 ADVOCATE OF AN UNSPECIFIED PATIENT REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD FRACTURED. AS A RESULT, THE DEVICE DELIVERED INAPPROPRIATE SHOCKS, THE DEVICE SYSTEM WAS REPROGRAMMED OFF. DETAILS SURROUNDING THE EXPLANT PROCEDURE WERE UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145853 NVY GUIDANT PUERTO RICO BV TACHY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1