BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2173358 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11100
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 15, 2011
    Report Date
    February 27, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENT INFORMATION WAS RECEIVED THAT APPROXIMATELY EIGHT MONTHS LATER, THIS DEVICE WAS OBSERVED TO HAVE MIGRATED INTO THE BREAST TISSUE. A REVISION PROCEDURE WAS PERFORMED. THE DEVICE WAS SUCCESSFULLY REPOSITIONED AND THE RA LEAD WAS ELECTIVELY EXPLANTED AND REPLACED WITHOUT INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE REMAINS IMPLANTED AND 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

    IT WAS UNKNOWN WHETHER THE PATIENT MEANT ONE OF THEIR LEADS HAD DISLODGED OR IF IT DISCONNECTED FROM THE DEVICE. THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE PATIENT IMPLANTED WITH THIS PACEMAKER, RIGHT ATRIAL AND RIGHT VENTRICULAR LEAD, THAT DURING A ROUTINE DEVICE CHECK, THE PHYSICIAN STATED THAT ONE OF THE LEADS WAS DISCONNECTED. IT WAS REPORTED THAT THE PHYSICIAN PLANNED TO PERFORM A REVISION AT A LATER DATE DUE TO ONE OF THE LEADS WAS STILL WORKING AND THE PHYSICIAN FELT THAT THE PATIENT DIDN'T NEED THE PACEMAKER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    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 64 YR S603| 4137| 4136