BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3224591 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-10784
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    August 30, 2011
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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

    - -

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION THIS DEVICE REMAINS IMPLANTED. AT THIS TIME, IT IS UNKNOWN WHETHER ADDITIONAL INFORMATION WILL BE OBTAINED. SHOULD FURTHER INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED. IT WAS THOUGHT THERE WAS SINUS ARREST THAT RESULTED IN CHRONOTROPIC INCOMPETENCE. EIGHT PERCENT ATRIAL UNDERSENSING WAS OBSERVED WHEN AUTO SENSITIVITY WAS PROGRAMMED "ON".

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE (AND NON-BSC RIGHT VENTRICULAR LEAD AND FLEXTEND 4096/171440); EXPERIENCED A COLLAPSE DUE TO AN UNKNOWN REASON. AT THIS TIME, AVAILABLE INFORMATION INDICATES ON THE SAME DATE, THIS DEVICE WAS INTERROGATED, HOWEVER, THE FINDINGS ARE UNKNOWN AND IT IS UNKNOWN WHETHER THE COLLAPSE WAS RELATED TO A DEVICE OR LEAD ISSUE. IN ADDITION, THERE WAS ATRIAL UNDERSENSING OBSERVED. NO FURTHER ADVERSE EFFECTS HAVE BEEN REPORTED SINCE THIS ADVERSE PATIENT EFFECT.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321346 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S602

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R