BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2244036 · Received August 24, 2011

    Report

    Report Number
    3004209178-2011-06777
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Report Date
    August 8, 2011
    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
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHOCKING OR JOLTING SENSATION OCCURRED FOLLOWING AN ENVIRONMENTAL EXPOSURE. REPORTEDLY, THE PT HAD STIMULATION ON AND WAS OVERSTIMULATED AFTER HE PASSED THROUGH A SECURITY GATE. ADDITIONAL 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 MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT # NJD118667N| LEAD: MODEL 3093, LOT # V583008