BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2173703 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11266
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003/S106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE OUTPUTS WERE PROGRAMMED TO PROVIDE A 2X'S SAFETY MARGIN AND THE FOLLOWING PHYSICIAN PLANNED TO MONITOR THE SITUATION FOR NOW. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT FOR THIS PULSE GENERATOR AND TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD HAD BEEN IN FOR A ROUTINE DEVICE FOLLOW UP WHEN NOISE AND POSSIBLE RIGHT VENTRICULAR LOSS OF CAPTURE WERE OBSERVED. THE PATIENT REPORTED NO SYMPTOMS. SOME NOISE WAS ABLE TO BE REPRODUCED ON THE LEAD. IT WAS SUSPECTED THAT THERE COULD BE A SETSCREW ISSUE OR A LEAD DISLODGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 4479| S606| 4457