BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2182307 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-05309
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION AND A LOSS OF THERAPEUTIC EFFECT AFTER BACKING INTO THE DOORKNOB. WHEN THE PT BACKED INTO THE DOORKNOB, SHE FELT A "POPPING" SENSATION IN THE AREA OF THE IMPLANTED NEUROSTIMULATOR. SYMPTOMS OCCURRED WHEN STIMULATION WAS TURNED ON. THE PT VISITED HER PHYSICIAN AND WAS REPROGRAMMED. ON (B)(6) 2011, THE PT FELT THE "POPPING" SENSATION IN THE POCKET SITE FOLLOWED BY A PAINFUL SENSATION. LOW IMPEDANCES WERE ALSO REPORTED (<250 OHMS). IT WAS ALSO NOTED THAT WHEN IMPEDANCES WERE MEASURED QUESTION MARKS WERE SHOWN IN THE RESULTS. ADD'L INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR PROGRAMMER: MODEL 3037, LOT# NJD122979N| LEAD: MODEL 3093, LOT# V612887| EXPLANTED:| IMPLANTED: