BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3052531 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04030
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 4, 2013
    Report Date
    April 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS ANALYZED. A LONGEVITY CALCULATION WAS PERFORMED, WHICH CONFIRMED THE DEVICE HAD FAILED TO MEET LONGEVITY EXPECTATIONS. THE DEVICE CASE WAS OPENED AND THE BATTERY WAS REPLACED WITH A POWER SUPPLY. ELECTRICAL MEASUREMENTS NOTED A HIGH CURRENT CONDITION. FURTHER DETAILED ANALYSIS ISOLATED THE HIGH CURRENT CONDITION TO A DEGRADED LOW-VOLTAGE CAPACITOR, CAUSING THE REPORTED FIELD OBSERVATION.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE PRE-IMPLANT TESTING, THIS DEVICE COULD NOT BE INTERROGATED WITH THE PROGRAMMER. THIS DEVICE WAS NOT IMPLANTED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ANOTHER DEVICE WAS SUCCESSFULLY IMPLANTED.

    Description of Event or Problem · 1

    - -

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156373 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S503

    Patients

    Seq Age Sex Outcome Treatment
    1