BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910920 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15603
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    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 THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A DROP IN IMPEDANCES, DECREASE IN SENSING AND AN INCREASE IN CAPTURE THRESHOLDS ABOVE THE ACCEPTABLE LEVELS. THE PATIENT UNDERWENT A REVISION PROCEDURE AND NO DAMAGE WAS OBSERVED ON THE LEAD. IT WAS SUSPECTED THAT THE LEAD EXHIBITED MICRODISLODGEMENT. THE LEAD WAS UNABLE TO BE REUSED AS IT WAS DESTROYED DURING EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18765 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R 1790| 0181| 0145| 1860| E102