BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3910441 · Received July 2, 2014

    Report

    Report Number
    2124215-2014-08701
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 5, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 WAS FOUND TO HAVE DISLODGED. ON REVIEW, THE PATIENT IS A TWIDDLER. A REVISION WAS PERFORMED TO REPOSITION THIS LEAD. OUR RECORDS INDICATE THAT THIS LEAD REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388319 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 296 MO Hospitalization| L| R E161| 0180