BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2519606 · Received April 6, 2012

    Report

    Report Number
    2124215-2012-00817
    Event Type
    Injury
    Date Received
    April 6, 2012
    Date of Event
    December 16, 2011
    Report Date
    January 16, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SURGICAL INTERVENTION WAS PERFORMED TO REVISE THIS RIGHT VENTRICULAR LEAD WHICH HAD DISPLAYED INCREASED THRESHOLDS AND A RISE IN PACING IMPEDANCE FROM 450 TO 1800 OHMS. THE LEAD WAS SURGICALLY ABANDONED, HOWEVER DURING REPLACEMENT IT WAS NOTED THAT THE LEFT SUBCLAVIAN VEIN HAD THROMBOSED. THEREFORE THE ENTIRE LEFT SIDED PACING SYSTEM WAS REMOVED FROM SERVICE AND A NEW PACING SYSTEM WAS IMPLANTED ON THE RIGHT SIDE OF THE BODY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 71 YR Hospitalization| L| R (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)