BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3223526 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-10028
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED NOISE EPISODES THAT WERE BEING OVERSENSED. INAPPROPRIATE SHOCKS WERE REPORTED BUT THERE WAS NO THERAPY EXHAUSTION. SHOCK LEAD IMPEDANCE TEST DISPLAYED GREATER THAN 200 OHMS. THERE WAS NO PACING ON RIGHT VENTRICULAR (RV) LEAD EVEN AT HIGH OUTPUTS. THE PATIENT WAS REPORTED TO BE NOT DEPENDENT. THIS RV LEAD WAS SURGICALLY REVISED WHERE IT WAS CAPPED AND WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321802 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 0181| 4136| E110