BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2944541 · Received February 5, 2013

    Report

    Report Number
    2124215-2013-02539
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OR RANGE SHOCKING IMPEDANCES OF GREATER THAN 200 OHMS. THE LEAD IS BELIEVED TO BE FRACTURED, AND AS A RESULT A REVISION WILL BE DONE TO REPLACE THE LEAD. AS OF TODAY, THE LEAD REMAINS IMPLANTED. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION BECAME AVAILABLE THAT THE OOR MEASUREMENTS WERE STILL PRESENT, SO A REVISION PROCEDURE WAS SCHEDULED. DURING THE PROCEDURE, IT WAS NOTED THAT THE PHYSICIAN FOUND A CONNECTION BETWEEN THE DEVICE HEADER AND THE LEAD, WHICH WAS CAUSING INTERMITTENT OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE DEVICE WAS EXPLANTED AND REPLACED AND THIS LEAD REMAINS IN SERVICE. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49521 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR N119| 0185| 4543| 4471