BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1944296 · Received December 6, 2010

    Report

    Report Number
    3004209178-2010-10222
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED INTERMITTENT AND STRONG, PAINFUL STIMULATION SENSATIONS FOLLOWING A FALL ON THE NEUROSTIMULATOR. SHE HAD TURNED THE DEVICE OFF WHEN THESE SENSATIONS OCCURRED. X-RAYS WERE TAKEN AND SHOWED NO ANOMALIES. IMPEDANCE MEASUREMENTS WERE OKAY WHEN INTERROGATED WITH THE CLINICIAN PROGRAMMER. THERE WERE NO FURTHER ACTIONS AT THE TIME OF THIS REPORT AND A DEVICE REPLACEMENT IS BEING CONSIDERED. NO PT INJURIES WERE REPORTED. IF ADD'L INFO BECOMES AVAILABLE A F/U REPORT WILL BE SENT.

    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