BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2182181 · Received July 7, 2011

    Report

    Report Number
    3004209178-2011-05197
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 11, 2011
    Report Date
    June 14, 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
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A BURNING SENSATION AT THE POCKET SITE. THE BURNING SENSATION OCCURRED WHEN STIMULATION WAS TURNED ON, AND WAS NOT TOLERANCE EVEN AT 1 VOLT. THE PT HAD FALLEN ABOUT THREE WEEKS PRIOR TO THE REPORT, BUT DID NOT BEGIN TO FEEL PAIN AT THE POCKET SITE UNTIL (B)(6) 2011. IMPEDANCE READINGS WERE WITHIN NORMAL LIMITS. REPROGRAMMING THE DEVICE HAD NOT HELPED. THE PT WENT TO HER PHYSICIAN'S OFFICE TO BE EVALUATED; HOWEVER, AFTER CHECKING IN, SHE DECIDED NOT TO BE SEEN BY HER PHYSICIAN. PT STATUS IS UNK.

    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 30 YR EXPLANTED:| LEAD: MODEL 3093, LOT# V513994| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD110510N