BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1961607 · Received December 27, 2010

    Report

    Report Number
    9614453-2010-10773
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 13, 2010
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS IMPLANTABLE NEURO STIMULATOR (INS) WAS ACTIVATED DUE TO A JET STREAM IN A SWIMMING POOL. THE INS WAS SWITCHED OFF WITH THE PT PROGRAMMER AND WAS WORKING NORMALLY AFTERWARDS. NO OUT OF RANGE IMPEDANCES OR OTHER DEVICE PROBLEM WAS IDENTIFIED WITH DEVICE INTERROGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MEDTRONIC EUROPE SARL 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1