BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2251091 · Received September 8, 2011

    Report

    Report Number
    3004209178-2011-07581
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    June 1, 2011
    Report Date
    September 1, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT NEVER HAD THERAPEUTIC EFFECT AND THAT SYMPTOMS (LOSS OF BLADDER CONTROL) WERE WORSE THAN THEY WERE BEFORE THE IMPLANT. THE PT HAD SAID THAT THE TRIAL WORKED GREAT, AND IT WAS REPORTED THAT THE IMPLANT PROCEDURE WENT WELL. IT WAS LATER REPORTED THAT THE PT EXPERIENCED A SURGING SENSATION WHILE STIMULATION WAS TURNED ON. THE STIMULATION HAD HELPED, BUT WAS NOT CONSISTENT. IN ADDITION, STIMULATION WAS SOMETIMES PAINFUL IN THE GROIN AREA. IT WAS REPORTED THAT THE PT HAD FOUR PROGRAMS, BUT HAD ONLY TRIED ONE OF THEM. IT WAS LATER REPORTED THAT THE DEVICE WAS ORIGINALLY ON PROGRAM 2, WAS CHANGED TO PROGRAM 1, AND REVERTED BACK TO PROGRAM 2 ON ITS OWN. IT WAS THOUGHT THE DEVICE HAD A HISTORY OF CHANGING PROGRAMS ON ITS OWN. THE PT WAS AGAIN SWITCHED TO PROGRAM 1 AT 1.7 VOLTS AND FELT A "NEEDLES" SENSATION, THOUGH THE SENSATION MAY HAVE BEEN DUE TO EXTERNAL PRESSURE APPLIED TO THE AREA WHILE HOLDING THE ANTENNA IN PLACE. THE PT HAD STIMULATION INCREASED TO 1.8 VOLTS, BUT THOUGHT IT WAS TOO STRONG AND RETURNED TO 1.7 VOLTS. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD DISCOMFORT "ABOUT SIX INCHES" BELOW THE IMPLANT. THE DISCOMFORT HAD BEEN PRESENT FOR "A COUPLE WEEKS" PRIOR TO THE REPORT AND WAS IN THE "BICYCLE SEAT AREA." THERE ARE NO RELATED FALLS OR TRAUMA. IT WAS ALSO REPORTED THAT THE PATIENT'S SYMPTOMS WERE NOT BEING CONTROLLED BY THE DEVICE AND WERE "WORSE THAN BEFORE THE IMPLANT." THE PATIENT STATED THAT THIS WAS THE CASE "THE WHOLE TIME SHE HAD HAD IT." THE DEVICE WAS TURNED OFF AND THE DISCOMFORT WAS "A LOT BETTER." THE PATIENT'S NEXT STEP WAS DISCUSSED, BUT NOT DECIDED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR IMPLANTED:| LEAD: MODEL 3093, LOT# V671771| PROGRAMMER: MODEL 3037, LOT# NJD127623N| IMPLANTED:| EXPLANTED:| EXPLANTED: