BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4131727 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14097
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 9, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 FROM A PRODUCT EXPERIENCE REPORT FORM THAT THIS PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY. THE CHRONIC DEVICE AND LEADS WERE EXPLANTED WITHOUT INCIDENT DUE TO INFECTION. THE PATIENT WAS STARTED ON ANTIBIOTICS. THE PATIENT WILL BE SCHEDULED FOR SYSTEM REPLACEMENT IN APPROXIMATELY SIX WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612649 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 10837 DA Hospitalization| L| O D013| 0181| 4136| E102