BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2780504 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12960
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 26, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    TECHNICAL SERVICES RESPONDED THE REASON FOR THE OUT OF RANGE NOT APPEARING IN THE MEASUREMENTS WAS DUE TO THEM BEING MEASURED EVERY TWENTY-ONE HOURS. IT WAS LIKELY THAT THE TWENTY-FOUR HOUR DAILY MEASUREMENT DISCREPANCY WAS LIKELY DUE TO TIMING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT POST IMPLANT OF THIS DEVICE; IT WAS NOTED THERE WAS RIGHT VENTRICULAR LEAD LOSS OF CAPTURE (FINELINE MODEL/SERIAL (B)(4)). DURING THE LEAD REVISION, THIS DEVICE SAFETY SWITCH WAS "ON'. THREE DAYS LATER, INTERROGATION A LEAD SAFETY SWITCH HAD OCCURRED AND HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS WERE INDICATED. THERE WAS NO INDICATION OF HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS PRIOR TO THE LEAD REVISION. HOWEVER DAILY MEASUREMENT DATA REVEALED THE HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS HAD BEEN RECORDED PRIOR TO THE REVISION PROCEDURE. NO ISSUES WERE NOTED WITH THE REPLACEMENT LEAD (DEXTRUS (B)(4)). AN INTERNAL TECHNICAL SERVICE (TS) CONSULTANT WAS CONTACTED FOR INFORMATION WHEN MEASUREMENT VALUES APPEAR IN THE DAILY MEASUREMENTS AND THE SAFETY SWITCH FEATURE FUNCTIONS AFTER IMPEDANCE MEASUREMENTS ARE OBTAINED. TS REVIEWED THE DATA AND DETERMINED THAT THE LEAD SAFETY SWITCH HAD LIKELY OCCURRED ONE WEEK POST IMPLANT DEPENDING ON THE DAILY MEASUREMENT TIMING. HOWEVER, FURTHER INFORMATION WAS REQUESTED REGARDING THE OUT OF RANGE MEASUREMENT TIMING. 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 S601

    Patients

    Seq Age Sex Outcome Treatment
    1 4137| S601| 4457