BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3200867 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11154
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 5, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28 LOT# V926977, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID NEU_PTM_PROG LOT# SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND THAT SHE WAS GOING TO THE BATHROOM ¿ALL THE TIME¿ WITH NO RELIEF FROM THERAPY. THE PATIENT WAS NOT SLEEPING BECAUSE, SHE WAS UP ALL NIGHT GOING TO THE BATHROOM. THE PATIENT CLARIFIED THAT THERE WERE NIGHTS SHE DID NOT GET UP AT ALL AND OTHERS WHERE SHE WAS UP ALL THE TIME. THE PATIENT WAS ABLE TO ¿CLOCK¿ WHEN SHE WILL NEED TO GO TO THE BATHROOM. THE PATIENT STATED THAT THE TRIAL SEEMED TO WORK EVEN THOUGH SHE WAS UP ALL NIGHT STILL. THE PATIENT STATED THAT SHE INCREASED STIMULATION ON HER CURRENT SETTINGS BUT THEN INCREASED IT TOO HIGH AND IT WAS PAINFUL. THE STIMULATION FELT LIKE ¿STEAK KNIVES¿ THAT ¿CAME AND WENT, THEN CAME BACK A FEW DAYS LATER.¿ THE PATIENT THEN DECREASED STIMULATION BUT IT WAS TOO LOW AND SHE HAD TO GO TO THE BATHROOM ALL THE TIME. THE PATIENT WENT TO HER HEALTH CARE PROVIDER (HCP) FOR PROGRAMMING AND IT LASTED FOR ¿A FEW DAYS¿ BUT THEN SHE WENT BACK TO GOING TO THE BATHROOM ALL THE TIME. THE PATIENT HAD A LOSS OF BLADDER CONTROL AND ALWAYS HAD THESE SYMPTOMS BUT AFTER IMPLANT ¿THINGS SEEMED TO BE BETTER FOR A LITTLE WHILE, BUT THERAPY WAS INCONSISTENT.¿ THE PATIENT STATED THAT HAD NEVER GOTTEN HER STIMULATION TO WORK. THE PATIENT STATED THAT IT SEEMED WORSE SINCE HER LAST PROGRAMMING IN (B)(6). AT THE REPROGRAMMING IN MAY THE PATIENT¿S HCP TESTED THE STIMULATION AND ASKED WHEN THE PATIENT FELT STIMULATION. THE PATIENT DID NOT AND HER HCP STATED ¿THAT WAS STRANGE.¿ HOWEVER, THE HCP STATED THAT THERAPY WAS ALRIGHT AND IT WAS FINE. THE PATIENT¿S HCP KEPT TELLING HER TO MAKE ADJUSTMENTS ON HER PROGRAMMER TO FIND RELIEF. THE PATIENT TOLD HER HCP THAT SHE HAD WORKED WITH ALL THE PROGRAMS AND NOTHING HELPED HER SYMPTOMS. THE HCP RECOMMENDED A BOTOX THERAPY. THE PATIENT WAS ASSISTED IN SWITCHING TO PROGRAM 4 AT 2.3 V OLTS. THE PATIENT WAS ¿LYING DOWN AND THEN SITTING UP¿ AND STIMULATION FELT LIKE A PULSING SENSATION. THE PATIENT HAD NOT SWITCHED PROGRAMS SINCE (B)(6) SO WANTED TO TRY THIS NEW PROGRAM. THE PATIENT ALSO NOTED THAT SHE HAD ¿SEIZURES¿ SO DID NOT WORK. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE THERAPY BUT WAS WORKING WITH THEIR DOCTOR AND THE MANUFACTURER¿S REPRESENTATIVE. AN APPOINTMENT OF (B)(6) 2013 WAS NOTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN OVERSTIMULATION SENSATION, A LOSS OF THERAPEUTIC EFFECT, AND A LOSS OF BLADDER CONTROL. THERAPY HAD NEVER WORKED. THE OVERSTIMULATION OCCURRED WHEN THE STIMULATOR WAS TURNED BACK ON. THE PATIENT HAD HAD THE STIMULATOR OFF FOR A LONG TIME DUE TO IT NOT WORKING. THE PATIENT NEEDED STIMULATION TURNED ON TO HELP THEIR URGENCY. THE PATIENT WAS NOT ABLE TO SYNC AND DECREASE STIMULATION DUE TO THE POOR COMMUNICATION SCREEN. REPOSITIONING THE ANTENNA AND REPLACING THE BATTERIES DID NOT RESOLVE THE ISSUE. THE PATIENT THEN SAW THE LOW PROGRAMMER BATTERY SCREEN. REPLACING THE PROGRAMMER BATTERIES RESOLVED THE ISSUE. THE STIMULATOR WOULD TURN ITSELF OFF AFTER A WHILE. STIMULATION WOULD START OUT OK AND THEN GET AGGRAVATING. BOTOX THERAPY HAD NOT HELPED. NO OUTCOME WAS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303212 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention