BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211042 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08369
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 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 ROUTINE TESTING, THIS RIGHT VENTRICULAR (RV) LEAD MEASURED A SHOCK IMPEDANCE OF ABOUT 170 OHMS. ADDITIONALLY, THE PACE IMPEDANCE MEASUREMENT WAS GREATER THAN 2000 OHMS. ALL OTHER PARAMETERS ARE NORMAL AND THERE WAS NO NOISE ON THE SHOCK CHANNEL. A REVISION PROCEDURE WAS PERFORMED 11 DAYS LATER, AND A DISCONNECTED DISTAL COIL WAS REPORTED. THE SOURCE OF THE OUT OF RANGE IMPEDANCE MEASUREMENTS WAS DUE TO A CONNECTION ISSUE WITH THE PULSE GENERATOR. ALL PRODUCTS WERE SUCCESSFULLY RECONNECTED WITH NORMAL MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310018 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R