BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2072522 · Received April 29, 2011

    Report

    Report Number
    2124215-2011-07566
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 DURING A DEVICE CHECK IT WAS NOTED THAT THE PATIENT HAD 2300 VENTRICULAR FIBRILLATION EVENTS THAT WERE DIVERTED DUE TO NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL. PACING INHIBITION OF TWO SECONDS WAS ALSO OBSERVED DURING THE RECONFIRMATION PERIOD. A CHEST X-RAY REVEALED THAT ALL THREE LEADS (RV, RIGHT ATRIAL AND LEFT VENTRICULAR) WERE KINKED AS THEY CAME OUT OF THE SUBCLAVIAN VEIN. IT WAS NOTED THAT THE PATIENT WAS ALSO IN ATRIAL FLUTTER, HOWEVER THE BOSTON SCIENTIFIC SALES REPRESENTATIVE STATED THAT HE WAS UNCERTAIN IF THE FLUTTER WAS REAL OR NOISE. THE PACEMAKER DEPENDENT PATIENT HAD PRESENTED TO THE DEVICE CHECK WITH SHORTNESS OF BREATH AND LIGHTHEADEDNESS, BUT HAD NO FURTHER SYMPTOMS AND WAS UNAWARE OF ANY ISSUES GOING ON WITH THE SYSTEM. A LEAD REVISION PROCEDURE WAS PERFORMED AND THE RV LEAD WAS FOUND TO BE FRACTURED DUE TO THE PLACEMENT OF A SUTURE DURING THE ORIGINAL IMPLANT PROCEDURE. IT WAS NOTED THAT THE SUTURE WAS NOT PLACED ON THE SUTURE SLEEVE AND OVER TIME HAD RUBBED THROUGH THE LEAD INSULATION AND CONDUCTOR WIRES, FRACTURING THE LEAD. THE CHRONIC RV LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE LEAD REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R 4470| 0158| 0180| H135| N118| H215| 4518