BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION -1X8

    MDR report key: 1901981 · Received November 12, 2010

    Report

    Report Number
    6000153-2010-09401
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    MPROC, VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PERI-OPERATIVE LEAD TESTING, IT WAS NOT POSSIBLE TO RECONNECT THE LEAD ANYMORE INTO THE EXTENSION. THE TESTING OF THE LEAD WAS NECESSARY BECAUSE, THERE WERE SOME HIGH IMPEDANCES. THE TESTING OF THE LEAD WAS NORMAL, SO THE PHYSICIAN WANTED TO RECONNECT THE LEAD WITH THE EXTENSION TO TEST OF THE IMPEDANCES ON THE BATTERY ONCE AGAIN (TO BE SURE). THE RECONNECTION WASN'T POSSIBLE SO THEY DECIDED TO CHANGE AND USE A NEW EXTENSION. THE PATIENT OUTCOME WAS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION -1X8 LGW MPROC, VILLALBA 37081

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention