BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1840073 · Received September 15, 2010

    Report

    Report Number
    3004209178-2010-07010
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    January 1, 2009
    Report Date
    August 30, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    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

    THE PT HAD A LOSS OF THERAPEUTIC EFFECT FOLLOWING A FALL "OVER A YEAR AGO". IMPEDANCE MEASUREMENTS ON SEVERAL ELECTRODE COMBINATIONS WERE > THAN 4000 OHMS. THE PT PLANNED TO HAVE THE DEVICE RE-PROGRAMMED. AN X-RAY WAS ALSO RECOMMENDED. ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3889, LOT# V094764| EXPLANTED:| EXTENSION: MODEL 3095, LOT# NAH038973V| PROGRAMMER: MODEL 3037, LOT# NJD067519N