BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2053404 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04698
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT PLANNED TO BE EXPLANTED DUE TO A PATIENT INFECTION. IT IS UNSURE IF THE PATIENT PRESENTED TO ANOTHER HOSPITAL FOR THE PROCEDURE, AS THE SALES REPRESENTATIVE HAS NOT SEEN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening 4402| H219| 4518| 0185| 4087| 4592