BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3083473 · Received April 29, 2013

    Report

    Report Number
    2124215-2013-07100
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 DISLODGED SHORTLY AFTER IMPLANT AND EXHIBITED INCREASED PACING THRESHOLDS. THE DISLODGEMENT WAS SUSPECTED TO BE DUE TO PATIENT ACTION BUT WAS NOT CONFIRMED AT THE TIME OF REPORT. A REVISION PROCEDURE WAS PERFORMED IN WHICH THE LEAD WAS SUCCESSFULLY REPOSITIONED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WAS MADE BUT WAS UNSUCCESSFUL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184521 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R 0295| E140