BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043319 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01789
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD DISPLAYED NOISE AND HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. A LEAD REVISION WAS PERFORMED. DURING THE PROCEDURE, IT WAS DETERMINED THERE WAS NO ISSUE WITH THE LEAD, BUT RATHER WITH THE DEVICE SET SCREWS. THIS LEAD WAS LEFT IMPLANTED AND IN SERVICE. A DEVICE REPLACEMENT PROCEDURE IS INTENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146047 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R