BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2052755 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03462
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEFT VENTRICULAR LEAD WAS NOT RETURNED TO BOSTON SCIENTIFIC. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD EXHIBITED LOSS OF CAPTURE DUE TO DISLODGEMENT. A REVISION PROCEDURE WAS PERFORMED AND THE RIGHT VENTRICULAR LEAD WAS SUCCESSFULLY REPOSITIONED WITH NORMAL MEASUREMENTS. IN ADDITION, THE LEFT VENTRICULAR LEAD HAD DISLODGED AND IT WAS NOT POSSIBLE TO REPOSITION THE LEAD IN AN APPROPRIATE LOCATION. THE LEAD WAS REMOVED AND THE LEFT VENTRICULAR PORT PLUGGED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention 4096| 0185| N119| 4543