BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2153550 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06359
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITION INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION VIA LATITUDE INFORMATION THAT LOSS OF CAPTURE AS WELL AS A RIGHT VENTRICULAR LEAD DISLODGEMENT WAS PRESENT. THE PATIENT WAS SEEN AT THE HOSPITAL WHERE THIS LEAD WAS REPLACED. THE LEAD WILL NOT BE RETURNED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED FOLLOWING THE REVISION PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention