BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3213668 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10225
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    November 17, 2012
    Report Date
    April 17, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 PRODUCT WAS INVOLVED IN INFECTION. THE LEAD WAS DETACHED AND HAD BACTERIA ON IT. THE FIELD REPRESENTATIVE WAS NOT ABLE TO IDENTIFY WHAT HAD SPECIFICALLY DETACHED AMONG THE LEADS AFTER ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ALL AVAILABLE INFORMATION INDICATES THAT THE PRODUCT REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312062 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R 4470| E110| 4312| 1861| 0158| 0041