BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2013-04683

    MDR report key: 3043379 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-04683
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 22, 2013
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 FROM A COMPETITOR REPRESENTATIVE THAT A PHYSICIAN THEY WERE WORKING WITH HAD EXPERIENCED DIFFICULTY IN RELEASING LEADS FROM THE HEADERS OF BOSTON SCIENTIFIC PACEMAKERS IN THE PAST. THERE WERE NO REPORTS OF ADVERSE PATIENT EFFECTS. THE STATUS OF THE INCLUDED DEVICE IS UNKNOWN AND NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146459 NVZ GUIDANT PUERTO RICO BV BRADY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 1283| 030-247| 4285| 0950| 0465