BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043579 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02728
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 ROUTINE FOLLOW UP VISIT, THIS RIGHT VENTRICULAR (RV) LEAD REVEALED HIGH THRESHOLD MEASUREMENTS, WHILE SHOCK AND LEAD IMPEDANCES REMAINED WITHIN RANGE. A MICRO LEAD DISLODGMENT WAS SUSPECTED OF THIS LEAD; THEREFORE DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED ON THIS PATIENT. THE DFT TEST WAS PERFORMED WITH NO COMPLICATIONS AND THE PATIENT WAS SAFELY CONVERTED AND PATIENT WAS IN NORMAL SINUS RHYTHM. A REVISION PROCEDURE WILL BE PERFORMED IN THE NEAR FUTURE TO REPLACE THIS LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145089 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R