BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSAR MAX II

    MDR report key: 2942503 · Received February 4, 2013

    Report

    Report Number
    2124215-2013-00589
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    February 1, 2007
    Report Date
    December 17, 2012
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FIELD REPRESENTATIVE. SHOULD ANY FURTHER INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED. ATTEMPTS TO GET ADDITIONAL INFORMATION FROM THE SALES REPRESENTATIVE WERE UNSUCCESSFUL. THERE WAS NO OTHER INFORMATION AVAILABLE. 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 CALLED STATING THAT THE PACEMAKER AND THE RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED DUE TO AN UNSPECIFIED MALFUNCTION. A NEW NON-BOSTON SCIENTIFIC SYSTEM WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46249 PULSAR MAX II IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1180

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 4087| MISMATCH| 4456| 1180