BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2781032 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13435
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 16, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. THE DEVICE CASE WAS OPENED TO FACILITATE EXAMINATION OF THE INTERNAL COMPONENTS. THE DEVICE BATTERY WAS REMOVED AND REPLACED WITH AN EXTERNAL POWER SOURCE. A BATTERY VOLTAGE WAS NOTED TO BE LOWER THAN EXPECTED. DETAILED ANALYSIS OF THE DEVICE HYBRID WAS UNDERTAKEN. THE HYBRID WAS UNFOLDED AND MICROSCOPIC ANALYSIS DID NOT IDENTIFY ANY CONDITIONS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE IDENTIFIED LOWER THAN EXPECTED BATTERY VOLTAGE. THE HYBRID WAS TESTED IN MANY DIFFERENT CONDITIONS, AT MANY DIFFERENT TEMPERATURES AND THE HIGH CURRENT DRAIN COULD NOT BE REPRODUCED. ANALYSIS CONFIRMED THE INABILITY TO INTERROGATE THIS DEVICE; HOWEVER, THE ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AT THE LAST FOLLOW-UP APPROXIMATELY SIX MONTHS PRIOR, THIS PACEMAKER EXHIBITED 1.5 YEARS OF REMAINING LONGEVITY. AT THIS RECENT DEVICE CHECK, THE MAGNET RATE WAS 90 AND REMAINING LONGEVITY WAS LESS THAN SIX MONTHS. THE IMPEDANCES HAD BEEN STEADY; HOWEVER, THE OUTPUTS HAD BEEN CHANGED AT THE PREVIOUS CHECK FROM 4 @ 0.5 TO 4 @ 0.9. TECHNICAL SERVICES DISCUSSED THE DEVICE FUNCTION AND SUGGEST A MEMORY REVIEW. THIS WAS TO BE DISCUSSED FURTHER WITH THE PHYSICIAN.

    Description of Event or Problem · 1

    THE PACEMAKER WAS EXPLANTED FOR NORMAL BATTERY DEPLETION AND WAS REPLACED WITH A NEW DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR 4470| S603| 4471| 1290