BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR MAX

    MDR report key: 2150839 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06237
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    April 4, 2011
    Report Date
    February 28, 2013
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND STATED THAT THIS DEVICE IS AT END OF LIFE, AND SHOULD BE REPLACED AS SOON AS POSSIBLE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. 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 THIS DEVICE WAS CHECKED THROUGH A TRANS TELEPHONIC MONITORING (TTM) CHECK AND WAS FOUND TO BE 100 BPM. THE DEVICE WAS CHECKED AGAIN TODAY AND IT WAS 85 BPM, AND THE DEVICE COULD NO LONGER BE INTERROGATED. SEVERAL TROUBLESHOOTING TECHNIQUES WERE TRIED AND STILL NO SUCCESSFUL INTERROGATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED THAT THIS DEVICE REMAINED IMPLANTED FOR A FULL YEAR AFTER THE UNSUCCESSFUL INTERROGATION ATTEMPT. AT THE CHANGE OUT THE DEVICE WAS ABLE TO BE NORMALLY INTERROGATED AND THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI), NOT END OF LIFE (EOL) AS PREVIOUSLY BELIEVED, REFUTING THE PREVIOUS ALLEGATION. THE DEVICE MET LONGEVITY PER DEVICE LABELING WITH NO EVIDENCE OF A DEVICE ISSUE AT CHANGE OUT WHICH WAS SUCCESSFULLY PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR MAX IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1270

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 4015| 1270| 4034