BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2193311 · Received July 13, 2011

    Report

    Report Number
    3004209178-2011-05392
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 20, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS SHOCKING AT POCKET SITE. PT WAS HAVING REVISION AS THERE WAS FLUID IN THE POCKET. THIS EVENT STARTED ONE WEEK AGO AND GOES AWAY WHEN STIMULATION WAS OFF. IT WAS REQUESTED TO VERIFY NO FLUID IN CONNECTOR BLOCK AND TO DO IMPEDANCES. 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 33 YR EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT #NJD122583N| LEAD: MODEL 3096, LOT 3V632934