BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2013-03424

    MDR report key: 3050133 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03424
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT AN ELECTROPHYSIOLOGIST ALLEGED THAT AN UNSPECIFIED LEAD HELIX HAD MALFUNCTIONED. THE PATIENT'S LEAD HAD DISLODGED. NO FURTHER IDENTIFYING INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152794 NVN GUIDANT PUERTO RICO BV BRADY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1