BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL

    MDR report key: 1926253 · Received November 11, 2010

    Report

    Report Number
    3007566237-2010-09282
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 5, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO REPORTING THE PT FELT PARESTHESIA IN THE HANDS AND FEET AFTER HAVING AN EKG. NO INFO WAS PROVIDED AS TO WHEN THE EKG WAS DONE OR IF THESE SYMPTOMS ARE PART OF THE PT'S UNDERLYING CONDITION. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, A F/U REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL LGW MEDTRONIC NEUROMODULATION IPG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CONVERSION TYPE: MODEL LEAD, LOT #: UNK| IMPLANTED:| EXPLANTED: