BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3153207 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01399
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 4, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD AN APPARENT FRACTURE. THE LEAD WAS REPLACED. THE PATIENT RECEIVED INAPPROPRIATE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256026 UNKNOWN PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| L| R