BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERVENE

    MDR report key: 2161199 · Received July 13, 2011

    Report

    Report Number
    2124215-2011-07685
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 2, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    PMA / PMN Number
    940008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED NOTED THAT THIS LEAD WAS REPLACED AND WAS DISCARDED AT THE HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL INFORMATION THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT HIGH OUT OF RANGE SHOCKING IMPEDANCES WERE SEEN ON THIS DF- SUPERIOR VENA CAVA LEAD. AN X-RAY WAS DONE SHOWED SOME DAMAGE ON THE LEAD. A BOSTON SCIENTIFIC REPRESENTATIVE WANTED TO OBTAIN EXAMPLES OF AN X-RAY OF THIS PARTICULAR LEAD AS WELL AS AN X-RAY APPEARANCE FROM TECHNICAL SERVICES. A RESPONSE FROM TECHNICAL SERVICES PROVIDED EXPLANATION REGARDING THE OUT OF RANGE SHOCKING IMPEDANCES AS WELL AS SOME EXPLANATION REGARDING THE APPEARANCE OF THIS TYPE OF LEAD. TECHNICAL SERVICES NOTED THAT DUE TO THE FACT THAT THIS LEAD IS A SUPERIOR VENA CAVA LEAD ANOTHER RIGHT VENTRICULAR LEAD SHOULD BE PRESENT, THUS IT IS POSSIBLE THAT OUT OF RANGE SHOCKING IMPEDANCES COULD BE AN ISSUE WITH THE 497-19 OR THE RIGHT VENTRICULAR LEAD COIL (COMPETITOR LEAD). AT THIS TIME THIS LEAD, 497-19 REMAINS IMPLANTED. A REVISION HAS BEEN SCHEDULED AND NO FURTHER PATIENT EFFECTS WERE REPORTED. THE SERIAL NUMBER OF THIS LEAD WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERVENE IMPLANTABLE LEAD NVY GUIDANT PUERTO RICO BV 497-19

    Patients

    Seq Age Sex Outcome Treatment
    1