BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 6928453 · Received October 9, 2017

    Report

    Report Number
    2124215-2017-12923
    Event Type
    Injury
    Date Received
    October 9, 2017
    Date of Event
    July 7, 2017
    Report Date
    July 7, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 LEAD WAS REVISED DUE TO EXHIBITING HIGH PACING THRESHOLDS; NO SYMPTOMS WERE REPORTED, REPORTEDLY PATIENT DOES NOT PACE. SURGICAL INTERVENTION WAS NEEDED TO RESOLVE THE ISSUE; THIS LEAD WAS REPOSITIONED. THIS LEAD WAS IMPLANTED RECENTLY; IT REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709108 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| L| R