BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW-L 85-BP

    MDR report key: 2212997 · Received August 9, 2011

    Report

    Report Number
    1028232-2011-01766
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD DISLODGED AND WAS SUCCESSFULLY REPOSITIONED (B)(6) 2011. THE LEAD DISLODGED A SECOND TIME AND WAS EXPLANTED ON (B)(6) 2011. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROX OTW-L 85-BP LV LEAD NKE BIOTRONIK SE & CO. KG 368346

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization