BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2930740 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-00999
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    June 24, 2014
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# V931558, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS FEELING PAIN AT THE POCKET SITE. THE POCKET SITE WAS STATED TO BE SWOLLEN AND 'WARMER THAN THE REST OF THEIR BODY.' IT ALSO 'DID NOT SEEM RED.' THE PATIENT COULD NOT SLEEP DUE TO THE PAIN AND IT WAS STATED THE PAIN ONLY WENT AWAY IF THEY 'BEND OVER OR STRETCH THE BACK OF THEIR RIGHT LEG.' THE PATIENT FELT 'SICK TO THEIR STOMACH' AND ALSO HAD A THYROID ISSUE. IT WAS NOTED THESE SYMPTOMS OCCURRED FOLLOWING A FALL ABOUT 4-5 DAYS AGO. WHEN STIMULATION WAS DECREASED, THE PATIENT'S SYMPTOMS WOULD RETURN. IT WAS NOTED THE PATIENT 'PEED THEIR PANTS' THE DAY PREVIOUS. IT WAS ALSO NOTED THAT STIMULATION HAD BEEN 'HITTING IN DIFFERENT AREAS.' STIMULATION WAS HELPING WITH THE PATIENT'S SYMPTOMS BEFORE THE FALL. THE PATIENT TRIED DIFFERENT PROGRAMS AND FOUND ONE WHERE STIMULATION MADE THEM FEEL DIZZY. THE PATIENT EXPERIENCED 'SHOOTING' PAIN IN THEIR PELVIC AREA AND HIPS. A DIFFERENT PROGRAM WAS TRIED AND THE STIMULATION WAS FELT MORE IN THE BICYCLE SEAT AREA. THIS WAS REPORTED AS 'MORE COMFORTABLE.' IT WAS STATED THE PATIENT HAD AN APPOINTMENT WITH THEIR HEALTHCARE PROVIDER ON (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTS STIMULATION IN THE WRONG LOCATION. IT WAS NOTED PAIN IN DIFFERENT AREAS. THE PATIENT WAS HAVING PROBLEMS WITH HER INTERSTIM AND THE EVENT DATE WAS NOTED SIX MONTHS POST-SURGERY. THE PATIENT STATES STIMULATION WAS FOR BLADDER. THE PATIENT STATES THE INTERSTIM HAS NOT WORKED FOR QUITE A LONG TIME BUT GUESS'S ABOUT 6 MONTHS POST-SURGERY. THE PATIENT STATES THE FIRST SIX MONTHS AFTER IMPLANT THE SYSTEM WORKED PERFECT BUT THEN THE STIMULATION STARTED CAUSING PROBLEMS WITH HER NERVES AND SHE HAD TO GO BACK TO THE HEALTHCARE PROVIDER WHO TRIED TO ADJUST THE STIMULATION. THE PATIENT STATES IT WAS CAUSING PAIN INSIDE HER STOMACH AND MAKING HER SICK. THE PATIENT STATES THE HEALTHCARE PROVIDER CHANGED THE DEVICE ON THE SETTINGS BUT IT KEPT CAUSING THE PAIN INSIDE HER. THE HEALTHCARE PROVIDER RESET THE STIMULATION AND TOLD THE PATIENT TO LEAVE IT AT "THIS CERTAIN LEVEL" BUT THE PATIENT COULD NOT LEAVE IT AT THE SAME LEVEL BECAUSE IT WAS TOO PAINFUL. THE PATIENT WAS MAKING A CLAIM THAT THIS THING WAS NOT FUNCTIONING PROPERLY AND IT WAS CAUSING PROBLEMS IN EVERY AREA OF HER LIFE AND IT WAS STARTING TO STIMULATE NERVES THAT SHE WAS NOT READY TO HAVE STIMULATED. SHE STATES THAT IT WAS CAUSING PROBLEMS AND STIMULATION EVEN WITH IT OFF. THE PATIENT STATES SHE TURNS IT BACK ON FOR A LITTLE BIT TO SEE IF IT IS IT STILL PAINFUL, BUT DOESN'T RECALL THE LAST TIME SHE TURNED IT ON AND OFF. THE PATIENT STATES SHE NEEDS SOMETHING THAT SHE CAN DO TO GET THIS THING OUT OF HER. THE PATIENT STATES SHE DOES NOT WANT TO GO BACK TO A HEALTHCARE WHO TELLS HER TO TRY SOMETHING ELSE. THE PATIENT STATES BECAUSE SHE HAD THE SYSTEM IN HER BODY FOR SO LONG, HER WHO BODY WAS BEING STIMULATED AND IN PAIN ALL OVER. THE PATIENT STATES SHE NO LONGER HAS INSURANCE AND SHE DOESN'T KNOW WHO WILL PAY FOR THE REMOVAL OF THE SYSTEM. THE PATIENT STATES WITH THE STIMULATOR OFF SHE PEES ALL OVER BUT WHEN SHE HAS STIMULATOR ON TO HELP HER GET FROM POINT A TO POINT B, THE PAIN WAS WORSE EVEN WHEN SHE TURNS DOWN STIMULATION TO LIKE A ONE BUT THERE WAS STILL PAIN THERE AND SHE WAS STILL HAVING PROBLEMS. THE PATIENT STATES SHE USED TO HAVE STIMULATION UP TO ABOUT A 3 AND STIMULATION DID WORK SHE COULD GO WHERE SHE NEEDED TO GO. THEN WHEN SHE LOWERED IT SHE WOULD PEE ALL OVER. THE PATIENT WAS CURRENTLY ON PROGRAM 3 BUT THERE WAS A LIGHTNING BOLT WHEN SHE TURNS IT ON. THE PATIENT STATES IT WAS AT 1.5 AND THEN PATIENT TUNED DOWN STIMULATION BECAUSE SHE STARTS TO MAKE HER FEEL NAUSEOUS. THE PATIENT STATES ANY TYPE OF STIMULATION STARTS TO MAKE HER FEEL SICK AND THE PATIENT STATES SHE NOW HAS NEUROPATHY PAIN AND WAS HAVING PROBLEMS WITH THE DEVICE SINCE IMPLANT . THE PATIENT WAS ABLE TO WALK AND LAY IN HER BED AND NOT FEEL ANY PAIN. THE PATIENT CANNOT HAVE A DEVICE IN HER BODY THAT WILL CAUSE HER ALL OF THESE PROBLEMS AND WANTS IT REMOVED AND WANTS TO KNOW WHO WILL PAY TO HAVE IT REMOVED AND WHO WILL REMOVE IT AND WHO WOULD PAY FOR IT AS SHE DOES NOT HAVE INSURANCE. THE PATIENT STATES THAT NO MATTER WHAT HAPPENS THE SYSTEM WAS CAUSING HARM. THE PATIENT STATES SHE WAS IN NEED OF HAVING A MRI AND SHE WAS HAVING PROBLEMS WHERE SHE CANNOT EVEN FUNCTION AND IT WAS BREAKING HER BODY DOWN AND THIS WAS A NEUROLOGICAL PROBLEM THE SYSTEM STIMULATES THE NERVES AND THAT MEANS THAT IF THIS WAS STIMULATING 5 SETS OF NERVES IT WILL CAUSE A NERVE PROBLEM AND IT WILL STIMULATE THE NERVES AND THEY WERE. IT WAS NOTED 1.5 MAKES HER FEEL LIKE A NERVOUS WRECK ON PROGRAM 3 IT HURTS THE RECTAL AREA. THE PATIENT WANTS TO HAVE THE SYSTEM REMOVED. THE PATIENT STATES THE TRIAL WENT WELL BUT FEELS IT WAS NOT LEFT ON LONG ENOUGH TO DETERMINE. THE PATIENT WAS CURRENTLY TO 0.0 AND OFF. THE PATIENT STATES SHE CAN'T USE THIS THING. THE PATIENT DOESN'T REMEMBER THE LAST TIME SHE WENT TO THE HEALTHCARE PROVIDER. THE PATIENT STATES SHE TURNED UP STIMULATION TO 7 AND DOESN'T FEEL A THING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36602 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other