BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 7196988 · Received January 16, 2018

    Report

    Report Number
    2124215-2018-00236
    Event Type
    Injury
    Date Received
    January 16, 2018
    Date of Event
    January 14, 2013
    Report Date
    December 13, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS CAPPED, THUS REMAINS IMPLANTED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FIVE YEARS AGO THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING NOISE ACROSS ALL THREE CHANNELS THOUGHT TO BE DUE TO CASTING, AS THE PATIENT IS A FLY FISHERMAN. THERE WAS AN INAPPROPRIATE MODE SWITCH DUE TO NOISE. NEW INFORMATION WAS RECEIVED THAT THERE WAS AGAIN NOISE ACROSS ALL CHANNELS. THE NOISE WAS NOW BEING OVERSENSED CAUSING PACING INHIBITION (NO ASYSTOLE) THAT WAS REPRODUCIBLE WITH ISOMETRICS. ALL OTHER MEASUREMENTS WERE WITHIN RANGE. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE RV LEAD WAS CAPPED AND REPLACED. THERE WERE NO SURGICAL OBSERVATIONS OBSERVED DURING THE REVISION THAT MIGHT HAVE GIVEN A ROOT CAUSE FOR THE NOISE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36796 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R