BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 2000398 · Received February 23, 2011

    Report

    Report Number
    MW5019476
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    June 1, 2010
    Report Date
    February 23, 2011
    Manufacturer
    UNK
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2004, HAD OPEN HEART SURGERY IN (B)(6) TO REPAIR A MITRAL VALVE. (B)(6) OF 2009, HAD HEART SURGERY IN (B)(6) TO REPAIR A TRICUSPID VALVE. (B)(6) 2010, STARTED FEELING ITCH AND NOTICED SKIN WAS PROTRUDING OUT. WENT TO SEE HER CARDIOLOGIST WHO SAID, THE WRONG WIRE PROTRUDING OUT. WENT BACK TO HER SURGEON IN (B)(6) WHO TOOK OUT AN 8 INCH PACEMAKER WIRE AND SAID, THE WIRE HAD MIGRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PACEMAKER WIRE DTB UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other