BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3685504 · Received March 18, 2014

    Report

    Report Number
    3004209178-2014-04581
    Event Type
    Injury
    Date Received
    March 18, 2014
    Report Date
    February 20, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA01ZR8, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT STILL FELT ¿SHOCKING¿ IN THE LOCATION OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS) EVEN THOUGH THE STIMULATION WAS TURNED OFF. IT WAS STATED A FEW WEEKS PRIOR TO REPORT THE PATIENT FELT A LOT OF THROBBING AND SIDE EFFECTS IN THEIR LEG LIKE DRAGGING AND NUMBING. THE PATIENT SHUT THEIR INS OFF AND TOOK THE BATTERIES OUT OF THE PROGRAMMER TO MAKE SURE IT STAYED OFF. IT WAS NOTED THE PATIENT WAS GOING TO HAVE THEIR DEVICE REMOVED BUT THEN THEY CHANGED THE PROGRAM. THE PATIENT STATED THAT TWO DAYS PRIOR TO REPORT THE INS STARTED GIVING OFF IMPULSES EVEN THOUGH THE PROGRAMMER WAS SHUT OFF. THE PATIENT DID NOT KNOW IF THERE WAS A CORRELATION OR NOT BUT THE LAST COUPLE DAYS PRIOR TO REPORT THEY HAD BEEN GETTING A SPASM OR ¿SHOCK¿ COMING INTO WHERE THE INS WAS. IT WAS NOTED THIS HAPPED AT DIFFERENT TIMES FOR A FEW MINUTES AT A TIME. THE PATIENT USED THEIR PROGRAMMER TO CHECK IF THE INS WAS OFF AND SAW A REPLACE PROGRAMMER BATTERIES WARNING SCREEN. THE PATIENT REPLACED THE BATTERIES AND CONFIRMED THE INS WAS OFF BECAUSE THERE WAS NO LIGHTNING BOLT. ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER STATED THEY HAD NOT EXAMINED THE PATIENT YET AND DID NOT KNOW THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HADN¿T BEEN USING THE IMPLANTABLE NEUROSTIMULATOR (INS) FOR A MONTH BECAUSE THEY FELT A FLASH OF PAIN WHERE THE INS WAS, WHICH STARTED 3 MONTHS AGO. THE PATIENT CALLED THEIR HEALTH CARE PROVIDER (HCP) AND THEIR MANUFACTURER REPRESENTATIVE AND THEY TOLD THEM THAT THE INS WAS DISCONNECTED AND THE PROGRAMMER BATTERIES WERE TAKEN OUT AND EVERY ONCE IN A WHILE THEY HAD INTERMITTENT PAIN AND WAS GETTING A ZING. IT WAS NOTED THAT THE PATIENT COULDN¿T RECALL IF THE STIMULATION WAS TURNED DOWN BEFORE THEY TURNED OFF THE INS. THE ¿TECH¿ TOLD THEM THAT THE PAIN WAS NOT COMING FROM THE DEVICE BUT THE PATIENT FELT IT RIGHT BY THE DEVICE AND THEY DIDN¿T CARE WHAT THEY SAID. IT WAS REPORTED THAT THE PATIENT THOUGHT IT WAS THE LEADS WHERE THEY WENT INTO THE DEVICE AND WAS THINKING TO REMOVE THE INS SINCE THEY DIDN¿T USE IT. IT WAS NOTED THAT THE PATIENT HAD NERVE DAMAGE IN THAT LEG ANYHOW AND THE IMPLANT MAY HAVE EXACERBATED THE DAMAGE AND TURNING IT OFF HAD HELPED WITH THE WALKING. THE PATIENT STILL HAD SOME SYMPTOMS BUT THEY DIDN¿T THINK THEY WERE RELATED TO THE DEVICE. THE PATIENT WANTED TO EVENTUALLY GET THE INS TAKEN OUT. IT WAS REPORTED THAT ALMOST FROM THE BEGINNING THE PATIENT NOTICED THE INS WAS NOT WORKING FOR THEM AND THOUGHT WHEN THEY WERE ON THE TRIAL IT HELPED SOMEWHAT. THE PATIENT¿S SYMPTOMS HAD EASED BUT THEY THOUGHT IT HAD CHANGED BECAUSE OF THEIR DIET.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WERE WORKING WITH THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE. THE PATIENT STATED THEIR DEVICE WAS AFFECTING THEIR WALKING AND THEY SHUT THE DEVICE OFF. IT WAS ALSO STATED THE PATIENT WAS STILL HAVING CONCERNS BUT HAD NOT SOUGHT FURTHER HELP. ADDITIONAL INFORMATION STATED THERE WAS NO KNOWN CAUSE OF THE EVENT AND THE PATIENT WAS ADVISED TO TURN THEIR STIMULATION DOWN. IT WAS NOTED THERE WERE NO KNOW INTERVENTIONS REQUIRED AND THE PATIENT'S ISSUE WAS BELIEVED TO BE RESOLVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN AND THE EVENT WAS ATTRIBUTED TO THE LEAD. THERE HAD BEEN NO INTERVENTIONS. IT WAS NOTED THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT AND THE PATIENT OUTCOME WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158187 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention