BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2173743 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11153
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 5, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RECORDS INDICATE THIS DEVICE REMAINS IN SERVICE. 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 INFORMATION WAS RECEIVED INDICATING THIS PACEMAKER WAS EXPLANTED AND UPGRADED TO A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). 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 IMPLANTED WITH THIS PACEMAKER WAS EXPERIENCING SYNCOPAL EPISODES. IT WAS REPORTED THAT THE PATIENT'S RATE WAS NOT BELOW 60 PACES PER MINUTE (PPM). THE LOWER RATE LIMIT WAS INCREASED TO 80 PPM TO MITIGATE THE SYNCOPAL EPISODES. 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 S201

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening S201| 4088