BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2172998 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10938
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION AND NO INFORMATION HAS BEEN RECEIVED. 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 PATIENT WAS EXPERIENCING PAIN AROUND THEIR IMPLANT SITE. THE PATIENT IS EXPERIENCING NUMBNESS AND COMPLAINING THAT THEIR DEVICE IS CAUSING THEM TO HAVE SEIZURES. ALSO, THEY EXPRESS CONCERNS ABOUT HOW THEY MAY AFFECT THE BATTERY LIFE OF THEIR DEVICE. THE PATIENT WAS SEEN IN THE HOSPITAL AND PROGRAMMING CHANGES WERE MADE.

    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
    1 296 MO S603| 4471| 4470