BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL II

    MDR report key: 1449792 · Received May 22, 2009

    Report

    Report Number
    6000032-2009-03617
    Event Type
    Malfunction
    Date Received
    May 22, 2009
    Report Date
    April 27, 2009
    Manufacturer
    MED REL, HUMACAO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT FELL ON THEIR CHEST. SINCE THE FALL THE PT HAS NOT BEEN FEELING WELL AND HAS EXPERIENCED TREMORING. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFERENCE MANUFACTURER REPORT # 6000032-2009-03618.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL II LGW MED REL, HUMACAO 7424 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| EXTENSION: MODEL 7495-51| IMPLANTED:| LEAD: MODEL 3389| EXPLANTED:| IMPLANTED:| LOT# QT2138228H| PROGRAMMER: MODEL 7438| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3389| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7424| EXTENSION: MODEL 7495-51