BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2173262 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11072
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 16, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT REVIEWED HOLTER MONITOR EKG STRIPS. AS DEVICE ELECTROGRAMS (EGMS) WERE UNAVAILABLE, TS WAS UNABLE TO DETERMINE A LIKELY CAUSE OF THE OVERSENSING. HOWEVER, TS DID NOT EVIDENCE THE COMPETITOR LEAD CONTRIBUTED TO THE EVENT, AND RECOMMENDED EVALUATING THE SYSTEM. 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 HAD EXHIBITED OVERSENSING PACING INHIBITION WITH PERIODS OF ASYSTOLE GREATER THAN TWO SECONDS. IT WAS REPORTED THE COMPETITOR LEAD IMPEDANCE WAS DECREASING. 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