BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2051986 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03974
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 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 A PROCEDURE WAS SCHEDULED TO EXPLANT THE DEVICE AND LEAD SYSTEM BECAUSE THE PATIENT HAD SEPSIS. THE POCKET HAD BROKEN OPEN AND THE DEVICE AS WELL AS THE LEADS WERE VISIBLE. THE PATIENT'S PRESSURE AND OXYGEN SATURATIONS DROPPED WHILE THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE RIGHT VENTRICULAR LEAD, SO THE PATIENT WAS INTUBATED AND TRANSPORTED TO THE OPERATING ROOM FOR SURGICAL REMOVAL OF THE LEAD AND TO REPAIR DAMAGE FROM THE ATTEMPTED REMOVAL. THE DEVICE AS WELL AS THE LEADS WERE EXTRACTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Life Threatening| O| R (B)(4)| H120| H170| 4542| 0184