BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL II

    MDR report key: 1220449 · Received October 31, 2008

    Report

    Report Number
    6000032-2008-07084
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 3, 2008
    Manufacturer
    MDT PUERTO RICO OPERTIONS CO, MED REL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FOLLOWING AN UNRELATED MEDICAL PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THEIR STATUS WAS REPORTED AS 'FAIR'. ON/OFF OPTIONS WERE DISCUSSED WITH THE HCP. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL II MHY MDT PUERTO RICO OPERTIONS CO, MED REL 7424 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR EXTENSION: MODEL 7495-51| EXPLANTED:| LEAD: MODEL 3387| IMPLANTED:| IMPLANTED:| EXPLANTED: