BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAGEWRITER XL COMPLETE LEAD SET AAMI

    MDR report key: 1250841 · Received November 25, 2008

    Report

    Report Number
    1218950-2008-00605
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Report Date
    July 21, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DPS
    PMA / PMN Number
    K895520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT REMOVING THE RL LEAD FROM THE STIMULATOR DID NOT RESULT IN A LEADS OFF INDICATION ON THE CARDIOGRAPH. THE LEADSETS WERE EVALUATED BY PHILIPS, AND WERE FOUND TO BE DEFECTIVE. THEY EXHIBITED VARIOUS DEGREES OF SHORTING. THE FAULTY LEADSETS WERE REPLACED, AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT REMOVING THE RL LEAD FROM THE STIMULATOR DID NOT RESULT IN A LEADS OFF INDICATION ON THE CARDIOGRAPH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAGEWRITER XL COMPLETE LEAD SET AAMI DPS PHILIPS MEDICAL SYSTEMS M1713B

    Patients

    Seq Age Sex Outcome Treatment
    1