BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY

    MDR report key: 6935501 · Received October 10, 2017

    Report

    Report Number
    2124215-2017-17432
    Event Type
    Injury
    Date Received
    October 10, 2017
    Date of Event
    September 17, 2017
    Report Date
    September 19, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THREE DAYS POST IMPLANT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS WITH LOSS OF CAPTURE (LOC). THERE WERE ALSO SEVERAL INSTANCES OF PREMATURE VENTRICULAR CONTRACTIONS (PVC) AFTER RV PACE. SURGICAL INTERVENTION WAS PERFORMED TO REPOSITION THE LEAD. THE LEAD WAS REPOSITIONED FROM THE RV TO THE RIGHT ATRIAL (RA) BUT THE LEAD DISLODGED. ATTEMPTS TO REPOSITION IT WERE UNSUCCESSFUL AS THE LEAD TIP GOT CAUGHT IN THE CHORDAE TENDINAE OF THE TRICUSPID VALVE. ATTEMPTS TO RELEASE THE LEAD WERE UNSUCCESSFUL. THE IMPEDANCE HAD DECREASED FROM 890 TO 220 OHMS. INSULATION DAMAGE WAS SUSPECTED AND THE LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717456 INGEVITY IMPLANTABLE LEAD LWP CPI - DEL CARIBE 7732

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R