BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 4120880 · Received September 26, 2014

    Report

    Report Number
    3007566237-2014-02708
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STARTED THE TRIAL YESTERDAY AND WAS NOT HAPPY WITH THE MANUFACTURER REPRESENTATIVE PROVIDING INSTRUCTION TO THEIR SPOUSE. THE PATIENT DID NOT UNDERSTAND HOW TO USE THE STIMULATION THERAPY AND WANTED INSTRUCTION. THE STIMULATION SENSATION WAS FELT PAINFULLY IN THE PATIENT¿S RIGHT TESTICLE AND IN THE KIDNEY AREA WHERE THEY PREVIOUSLY FELT A KIDNEY STONE. THE PATIENT TURNED THE STIMULATION OFF AROUND MIDNIGHT AND THEN BACK ON AGAIN. THE PATIENT HAD AN OVERSTIMULATION SENSATION AND LAST NIGHT THE SETTING WAS AT 2.8V. THE PATIENT TURNED IT DOWN TO 2.0V AND WOULD TURN IT DOWN FURTHER. THE PATIENT WAS STILL PEEING A LITTLE BIT AND WOULD TURN IT DOWN A BIT MORE. IT WAS MENTIONED THAT THEY PUT IN JUST 1 LEAD. THE PATIENT HAD 9 BACK SURGERIES AND HAD TITANIUM RODS FROM L4 OR L5 TO S1. THE PATIENT¿S LEFT LEG HAD NEUROPATHY AND THEY HAD TO WEAR A SOCK AT ALL TIMES. DURING THE TRIAL THEY TOOK THE PATIENT¿S SOCK OFF AND THEY SAT UP AND PUT IT BACK ON. THE PATIENT WAS SEDATED AND THE TRIAL WAS A FULL SURGERY. THE PATIENT WAS NOT TRAINED ADEQUATELY ON USING THE DEVICE AND ALL THEY HAD WAS A GREEN SHEET OF PAPER THAT SAID STAGE 1 AND ON THE BACK THE ADDITIONAL INFORMATION WAS BLANK. THERE WAS NOTHING SAID ABOUT KEEPING A RECORD OR ANYTHING BUT THE MANUFACTURER REPRESENTATIVE MAY HAVE TOLD THEIR SPOUSE, BUT IT FLEW OVER THEIR HEAD. THE NEXT DAY IT WAS REPORTED THAT THE PATIENT¿S STREAM HAD GONE BACK LIKE IT WAS WHERE IT WAS INCONSISTENT WHEN THEY URINATED AND THEY HAD A PAIN PROBLEM ALL NIGHT IN THEIR SCROTUM AND IN THE FRONT IN THAT AREA. THE PATIENT HAD SOME PAIN IN THEIR KIDNEY AND WAS HAVING THE SAME PAIN YESTERDAY UP FRONT LIKE KIDNEY STONES. THE PATIENT DID NOT HAVE THAT PAIN PRIOR TO THE STIMULATOR AND IT DID NOT GO AWAY WHEN THEY TURNED DOWN THE STIMULATOR. IT WAS NOW SET AT 3.5V THE PATIENT HAD TO SET IT AT 4V BEFORE THEY FELT THE TINGLING. THE STIMULATOR WAS CAUSING THE PATIENT MORE PAIN PRIMARILY ON THE RIGHT SIDE OF THE SCROTUM, PAIN IN THE KIDNEYS, AND PAIN IN THE LOW BACK THAT STARTED YESTERDAY. THE PATIENT WOKE UP AT 4AM DUE TO THE PAIN AND THEY TURNED THE STIMULATION OFF AND THE PAIN WENT AWAY. THE STIMULATOR WAS HELPING WITH THE STREAM YESTERDAY, BUT TODAY IT HAD GONE BACK TO AN IRREGULAR STREAM. THE PATIENT LEFT A MESSAGE FOR THEIR HEALTH CARE PROVIDER (HCP) 2 DAYS AGO BECAUSE THEY WERE IN SO MUCH PAIN AND TURNED OFF THE STIMULATOR AND TURNED IT BACK ON YESTERDAY MORNING. THE PATIENT ALSO LEFT A MESSAGE T HIS MORNING FOR THEIR HCP, BUT HAD NOT RECEIVED A CALL BACK. IT WAS LATER REPORTED THAT THE PATIENT HAD STIMULATION IN THE WRONG LOCATION. THE PATIENT WENT TO SEE THEIR HCP YESTERDAY TO RECALIBRATE THE SCREENER BOX. FOLLOWING THE APPOINTMENT THE PATIENT WENT HOME, FELT EXHAUSTED, AND LIED DOWN ON THE COUCH AND THEY BEGAN FEELING VIBRATION IN THEIR SPINE. THE PATIENT FELT STIMULATION INSIDE THEIR SPINE AND NOT AT THE SACRAL NERVE BUT AT THE LOCATION OF THE SCREENER BOX SITE. IT WAS NOT AT THE INCISION OR WIRE COMING OUT OF THE SKIN, BUT THE VIBRATION WAS IN THE SPINE NOT THE SKIN WHERE THE SCREENER BOX ON THE LINE WAS ON THEIR SPINE. THE SCREENER BOX WAS PRESSED UP AGAINST THE PATIENT¿S SPINE AND THEY FELT VIBRATIONS INSIDE OF THEM AT THAT LOCATION. IT WAS AT THE WAISTBAND WHERE THE SCREENER BOX RESTED AGAINST THE SKIN, BUT THE PATIENT DID NOT FEEL IT THROUGH THE SKIN THEY FELT IT IN THE NERVE OF THEIR SPINE RIGHT AT THEIR WAIST. THE PATIENT LIED DOWN IN BED AND THEIR SPOUSE COULDN¿T WAKE THEM UP AND EVERY TIME THEY TRIED THE PATIENT WOULD JUST ROLL OVER. TEN HOURS LATER, THE PATIENT WOKE UP SHAKING LIKE THEY WERE COLD, BUT THEY WEREN¿T COLD AND IT WAS THE WHOLE SYSTEM WAS VIBRATING. THE PATIENT TURNED THE SCREENER BOX OFF AND CONTINUED VIBRATING FOR ANOTHER HOUR AND THE PATIENT WANTED TO KNOW IF THIS WAS NORMAL. THE PATIENT¿S SACRAL AREA HURT AND AFTER TRIAL IMPLANT THEY THOUGHT IT WAS THE INCISION CAUSING THE PAIN BUT IF THEY TOUCHED THE SACRAL AREA THE PAIN LEVEL WAS AT 8 OUT OF 10. TODAY THEY REALIZED THE PAIN WAS AT THE SACRAL NERVE AND NOT AT THE INCISION SITE. THE PATIENT CALLED THE HOSPITAL AFTER WAKING UP FROM THE 10 HOUR SLEEP AND THEIR HCP TOLD THEM TO CALL THE MANUFACTURER. IT WAS LATER REPORTED THAT THE PATIENT HAD SEVERAL ISSUES WITH TRIAL AND WANTED TO CUT THE CORDS OFF. THE PATIENT¿S BODY STARTED SHAKING AND SHIVERING AND THEY STARTED THE TRIAL LAST WEEK SOMETIME AND IT HAD BEEN A DISASTER. THE PATIENT JUST GOT BACK FROM THE EMERGENCY ROOM (ER) BECAUSE OF IT. THE HCP MADE AN APPOINTMENT AND WHEN THEY GOT HOME THEY FELT THE ROUND TUBE, OR THE LEAD, NEXT TO THEIR SPINAL CORD AND THE VIBRATION WAS GETTING INTO THEIR SPINAL CORD. THE PATIENT WAS SO TIRED THEY LIED DOWN AROUND 11AM AND AT 7PM THEY WOKE UP WITH SHIVERS. THE PATIENT¿S SPOUSE TRIED TO WAKE THEM AND THE PATIENT DIDN¿T REMEMBER ANY OF THIS. THE STIMULATION HAD BEEN OFF SINCE 7PM LAST NIGHT AND THE PATIENT WANTED TO CUT THE WIRE BECAUSE IT KEPT FALLING DOWN. THE THERAPY ONLY WORKED FOR THE PATIENT FOR PART OF A DAY AND THEN THEY STARTED HAVING TO ADJUST IT. THE MANUFACTURER REPRESENTATIVE DID NOT GIVE THE PATIENT ANY INSTRUCTION ON THE DAY THEY STARTED THE TRIAL AND SPENT THE TIME TALKING TO THE PATIENT¿S SPOUSE AND THE PATIENT HAD NO CONTACT WITH THEM. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT HEALTH CARE PROVIDER DID NOT FEEL PATIENT WAS A GOOD CANDIDATE FOR SACRAL NERVE STIMULATION (SNS) BECAUSE OF HIS BACK ISSUES. HE HAD COMPLETED HIS TRIAL AND AFTER TURNING DEVICE OFF HE DID NOT CONTINUE TO HAVE ANY IF THE SIDE EFFECTS RELATED IN THE PREVIOUS CALLS. ALL SYMPTOMS HAVE RESOLVED IN CONJUNCTION WITH SNS THERAPY AND DEVICE. IT WAS LATER REPORTED THAT THERE WERE NO MALFUNCTIONS, THE PATIENT DIDN'T LIKE IT AND IT DIDN'T HELP HIM WITH HIS URINARY SYMPTOMS AND THAT WAS WHY IT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602049 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3625

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention