BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2284648 · Received October 10, 2011

    Report

    Report Number
    2124215-2011-16220
    Event Type
    Injury
    Date Received
    October 10, 2011
    Date of Event
    September 12, 2011
    Report Date
    September 12, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT EXPERIENCED A SYNCOPAL EPISODE FOR AN UNKNOWN REASON. THE FIELD REPRESENTATIVE PERFORMED A DEVICE INTERROGATION THAT SHOWED THE DEVICE WAS FUNCTIONING AS INTENDED. NO EVENTS WERE STORED IN THE ARRHYTHMIA LOGBOOK AND NO NOISE WAS SEEN WITH ISOMETRICS. REVIEW OF TRENDING DATA REVEALED THAT THE PATIENT'S HEART RATE WAS IN THE 90 BPM RANGE AND THEN DROPPED TO HER LOWER RATE LIMIT (LRL) OF 60 BPM. IT WAS NOTED THAT THE PATIENT ONLY PACES 33 PERCENT OF THE TIME. THE LRL WAS SUBSEQUENTLY INCREASED FROM 60 TO 70 PPM. NO ADDITIONAL 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 82 YR Life Threatening| R S601| 4136