BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043301 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02245
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 21, 2013
    Report Date
    March 4, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT WILL BE UPDATED WHEN THE LEAD REVISION IS PERFORMED.

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION. THE ENTIRE SYSTEM WAS EXPLANTED AND WAS NOT REPLACED. THE PATIENT DID NOT FEEL THE DEVICE WAS IMPROVING HIS QUALITY OF LIFE AND THEREFORE DID NOT WISH TO HAVE A NEW DEVICE AND LEAD IMPLANTED. THE CLINICIAN REPORTED TO THE FIELD REPRESENTATIVE THAT THE LEAD WAS EXTRACTED WITH NO COMPLICATIONS. THE EXPLANTED LEAD WAS NOT EXPECTED TO BE RETURNED. 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 DURING A ROUTINE FOLLOW-UP, IT WAS NOTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS DISLODGED. THE PATIENT WAS NOT PACEMAKER DEPENDENT. AN X-RAY WAS PERFORMED, CONFIRMING THE DISLODGEMENT. THE PATIENT WAS SENT HOME PENDING A LEAD REPOSITIONING PROCEDURE, TO BE SCHEDULED FOR A LATER DATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146041 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1