BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3911629 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-10408
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION HOWEVER WAS UNSUCCESSFUL. ALL AVAILABLE INFORMATION SUGGEST THAT THE STATUS OF THE PRODUCT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391187 ENDOTAK RELIANCE NVY GUIDANT PUERTO RICO BV 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R