BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3052576 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-03817
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE RV LEAD REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT WILL BE SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP VISIT, THIS RIGHT VENTRICULAR (RV) LEAD REVEALED NOISE. IN ADDITION, APPROXIMATELY THREE SECONDS OF VENTRICULAR LOSS OF CAPTURE WAS OBSERVED DURING REPRODUCTION OF THE NOISE. THIS PATIENT IS PACEMAKER DEPENDANT. A REVISION PROCEDURE WAS TO BE PERFORMED IN THE NEAR FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155221 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R 0175| H230| 5076| 4555