BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3213687 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09749
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    November 1, 2011
    Report Date
    May 23, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 THIS RIGHT VENTRICULAR (RV) LEAD WAS LIKELY SLICED DURING THE PLACEMENT OF A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE PATIENT WAS EVALUATED OVER A YEAR LATER AND LOSS OF CAPTURE WAS OBSERVED ALONG WITH LEAD IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THE PATIENT HAD AN UNDERLYING SINUS RHYTHM. FURTHERMORE, THE PATIENT HAD AN INFECTION WHICH IS NOT RELATED TO THE DEVICE AND THERE IS NO PLAN FOR INTERVENTION AT THIS TIME. THE LEAD WAS COMPLETELY SEVERED WITH THE PORTION STILL ATTACHED TO THE PATIENT'S DEVICE EXPLANTED AND THE REMAINDER WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314260 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 0184| 4469| 4193| 4076| 4017| 4537| 1853| H217| 3830| 0148| N119| 4542