BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2241064 · Received August 17, 2011

    Report

    Report Number
    3004209178-2011-06503
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 28, 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
    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 FOLLOWING A BILATERAL MASTECTOMY. THE PT HAD BRUISING ACROSS HER LOWER BACK AND NEUROSTIMULATOR FOLLOWING SURGERY, BUT IT WAS NOTED THAT THE PHYSICIAN INDICATED THIS WAS NORMAL AFTER SURGERY. THE PT WAS HAVING "MORE ACCIDENTS" AND HAD GONE THROUGH ALL THE PROGRAMS, BUT WAS UNABLE TO "GET THINGS UNDER CONTROL". PROGRAM 1 WORKED THE BEST BUT THE PT COULD NOT TOLERATE SETTINGS ABOVE 4.1 VOLTS. 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 68 YR LEAD: MODEL 3889, LOT# V514032| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD111414N| EXPLANTED: