BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2191831 · Received July 22, 2011

    Report

    Report Number
    3004209178-2011-05672
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    January 1, 2010
    Report Date
    June 27, 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. ALSO, THERE WAS A PAIN IN HER BACK, BUTTOCKS AND HIP DUE TO THE DEVICE. FOR EXAMPLE, THE PT WAS STANDING IN LINE AND ALL OF A SUDDEN SHE FELT A SHOCKING SENSATION OR OVERSTIMULATION. THE STIMULATION WAS IN THE WRONG LOCATION. THIS ISSUE HAD BEEN PRESENT FOR OVER A YEAR. IT WAS RECOMMENDED THAT THE PT VISIT THEIR HCP TO GET THE DEVICE INTERROGATED. 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 53 YR EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V276423| PROGRAMMER: MODEL 3037, LOT# NJD092061N