BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3163268 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10172
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3058, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3889-28, LOT # V914059, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3889-28, LOT # V914059, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    INFORMATION REVIEWED INDICATED THAT IT WAS ¿LIKE ONCE IT WAS STICKING OUT IT MIGRATED SOMEWHERE ELSE IN THERE¿. IT WAS ALSO ADDED THAT PRESSING ON IT DOES NOT HELP TO BRING IT BACK INTO POSITION. IT WAS ALSO ADDED THAT IT WAS JUST REALLY UNCOMFORTABLE.A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE ARE TIMES THE DEVICE FELT LIKE IT WAS ¿BURNING INSIDE.¿ THE PATIENT NOTED THAT SOMETIMES WHEN SHE PUT HER HAND OVER THE DEVICE TO APPLY PRESSURE SHE FELT THE ¿BURNING SENSATION,¿ BUT SHE DID NOT HAVE TO TOUCH IT TO FEEL THE ¿BURNING SENSATION.¿ THE PATIENT STATED THAT IT HAPPENED ¿EVERY ONCE IN A WHILE.¿ THE PATIENT ALSO SAID THAT ¿YOU COULD SEE CHANGES IN THE TISSUE AROUND THE DEVICE WHEN STIMULATION WENT ON AND OFF.¿ THERE WERE ALSO TIMES WHEN THE PATIENT FELT LIKE IT WAS WET AT THE IMPLANT SITE, ¿FELT AS THOUGH IT SUDDENLY GOT WET,¿ BUT SHE TOUCHED IT AND NOTHING WAS THERE. THE PATIENT HAD BEEN HAVING ¿A LOT OF PROTRUSION¿ AT THE IMPLANT SITES. IT WAS ¿SOMETIMES¿ WELL DEFINED AND OTHER TIMES NOT. THE PATIENT WAS ABLE TO SEE THE CORNERS OF THE IMPLANT AND IT WAS BECOMING THAT WAY ON BOTH SIDES, CAUSING ¿INTENSE PAIN¿ AND IT WAS GETTING WORSE. THE DAY OF THE REPORT IT WAS ON BOTH SIDES. THE ISSUE BEGAN ON THE RIGHT SIDE WHERE IT ¿COMES AND GOES AND LASTS FOR 2-3 DAYS.¿ THE PATIENT STATED THAT THE PROTRUSION WAS ¿NOT POSITIONAL AND PRESSING ON IT DID NOT HELP.¿ THE PATIENT NOTED THAT CHANGING POSITIONS MADE IT WORSE AND WHEN THE CORNERS OF THE DEVICE ARE BULGING OUT SHE WAS ¿ABLE TO SEE IT THROUGH HER CLOTHES.¿ THERE WAS ¿UGLY BRUISING¿ WHERE THE PROTRUSION WAS. ¿A FEW DAYS AGO¿ THE DEVICE ON THE RIGHT SIDE WAS STICKING OUT WHAT ¿FELT LIKE 2-3 INCHES¿ BUT A FAMILY MEMBER SAID IT ¿LOOKED LIKE ¼ OF AN INCH.¿ THE PATIENT STATED THAT THE ¿RIGHT SIDE WENT DOWN AND THE PROTRUSION MOVED TO THE LEFT SIDE.¿ THE PATIENT NOTICED BRUISING ON THE LEFT SIDE ON (B)(6) 2013. AT THE TIME OF THE REPORT THERE WAS ¿A LITTLE BRUISING¿ ON THE RIGHT SIDE. THE PATIENT ALSO REPORTED THAT FOR THE ¿PAST FOUR DAYS¿ SHE HAD HAD ¿HORRENDOUS¿ BACK PAIN, BUT WAS NOT SURE IF IT WAS DEVICE RELATED OR A RESULT OF ¿THE STORMS THEY HAVE HAD.¿ THE PATIENT ¿HAD BEEN VERY ILL FOR SEVERAL YEARS AND SPENT MOST OF HER LIFE IN BED.¿ THERE WERE NO FALLS OR TRAUMA. THE PATIENT HAD NEVER TRIED TURNING STIMULATION OFF. THE PATIENT SAW HER HEALTH CARE PROVIDER ¿MONTHS AGO¿ WHERE REPROGRAMMING WAS DONE BUT THE PROTRUSION ISSUE WAS NOT ADDRESSED. THE PATIENT STILL HAD SYMPTOM CONTROL, BUT ¿LATELY¿ FELT LIKE SHE WAS GOING MORE OFTEN. IT WAS NOT AS MUCH AS PRIOR TO IMPLANT, BUT IT WAS NOT AS EFFECTIVE AS IT WAS RIGHT AFTER IMPLANT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263577 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1