BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3040987 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04864
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 16, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-33 LOT# VA04AA7, IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3037 LOT# 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 EXPERIENCED A "BURNING SENSATION IN BOTH HER FEET" WHEN HER IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED ON. IT WAS FURTHER REPORTED THAT THE PATIENT'S "RIGHT FOOT FELT LIKE IT WAS ON FIRE WHEN STIMULATION WAS ON FOR ONLY A FEW MINUTES." THE PATIENT NOTED HER INS'S AMPLITUDE OF 0.2 WAS "VERY LOW" AND THAT "EVEN THE LOW SETTING WAS TOO MUCH TO HANDLE" AND "TOO PAINFUL." IT WAS STATED, THE PATIENT "KEPT CHECKING TO MAKE SURE STIMULATION WAS IN OFF SETTING." THE PATIENT FURTHER NOTED THAT AFTER TURNING THE INS OFF THREE DAYS PRIOR TO REPORT, SHE EXPERIENCED "SHOCKING SENSATIONS" IN BOTH HER LEGS. IT WAS ADDITIONALLY STATED, THE PATIENT "DIDN'T FEEL LIKE THE THERAPY WAS COMPLETELY SHUTTING OFF." THE PATIENT ADDITIONALLY NOTED THAT HER DOCTOR ADVISED HER THE DAY PRIOR TO REPORT THAT "IT WAS NOT POSSIBLE TO FEEL SHOCKING IN THE LEFT SIDE DUE TO HER IMPLANTED LEAD WIRE" AND THAT "IT COULD HAVE BEEN NERVE MEMORY THAT SHE WAS EXPERIENCING." IT WAS REPORTED THAT THE PATIENT HAD TRIED "ALL FOUR PROGRAMS" TWO DAYS PRIOR TO REPORT AND THAT EACH "RESULTED IN THE SAME BURNING SENSATION IN HER FEET." THE PATIENT STATED, SHE HAD BEEN "NOT ABLE TO SLEEP" FOR THE THREE DAYS PRIOR TO REPORT "BECAUSE OF THE SHOCKING SENSATION IN HER CALVES AND FEET." THE PATIENT ADDITIONALLY REPORTED SHOCKING HERSELF EVERY TIME SHE CHANGED SETTINGS. THE PATIENT WAS REDIRECTED TO HER HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT¿S LEAD PLACEMENT WAS ¿BAD¿ SINCE IMPLANT AND NO PROGRAMMING HAD HELPED. THE PATIENT SHUT THERAPY OFF TWO MONTHS AGO AND KEPT GETTING SHOCKS IN THE RIGHT FOOT DUE TO THE LEAD PLACEMENT, EVEN WITH THERAPY OFF. THEY COULDN¿T GET THE SHOCKING OUT OF THE RIGHT FOOT. THE PATIENT WAS IN THE PROCESS OF TRYING TO GET THE DEVICE TAKEN OUT BUT COULDN¿T FIND A SURGEON WHO WAS WILLING TO TAKE THE DEVICE OUT. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS LOOKING FOR A NEW DOCTOR WHO WAS CLOSER. THE PATIENT HAD MOVED TO ANOTHER STATE AND NEEDED TO FIND A HCP (HEALTHCARE PROVIDER) IN HER AREA. THE PATIENT WAS STILL WORKING WITH HER HCP IN THE PRIOR STATE BUT THE PATIENT WAS TRYING TO GET INSURANCE APPROVAL TO GET THE INTERSTIM OUT AND WAS HAVE DIFFICULTIES. THE PATIENT NOTED EITHER THE HCP'S WON'T TAKE ON ANOTHER HCP'S PATIENT OR SHE HAS TO WAIT UNTIL (B)(6) 2015 TO GET IN. THE PATIENT COULD NOT WAIT THAT LONG. THE PATIENT DID HAVE AN APPOINTMENT SET UP IN (B)(6). THE PATIENT HAD HAD ISSUES WITH SHOCKING IN HER RIGHT FOOT AND LEG SINCE IMPLANT DUE TO LEAD WIRE PLACEMENT. WHEN THE PATIENT TURNS STIM ON THE SHOCKING WAS MORE INTENSIFIED BUT IT WAS STILL SHOCKING HER WHEN SHE TURNED IT OFF. THE PATIENT HAD TRIED REPROGRAMMING BUT NOTHING HAD HELPED HER SITUATION. THE PATIENT STATED SHE NEEDED TO FIND SOMEONE TO RUN A DIAGNOSTIC ON HER DEVICE TO MAKE SURE EVERYTHING WAS OFF. A FIELD STAFF REQUEST WAS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143373 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1