BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2770800 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-08840
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Report Date
    September 5, 2012
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V521988, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT WHILE THE STIMULATION WAS TURNED ON. PATIENT WAS LEAKING URINE 'LIKE CRAZY.' THE DEVICE WAS WORKING FINE FOR ABOUT A YEAR. AROUND THE BEGINNING OF THE YEAR, THE PHYSICIAN'S ASSISTANT ADJUSTED THE STIMULATOR, AND PATIENT HAD BEEN HAVING PROBLEMS SINCE. BEFORE THE DOCTOR'S VISIT, PATIENT WAS HAVING THERAPEUTIC EFFECT. PATIENT HAD TO GO BACK TO THE DOCTOR TO MAKE SEVERAL ADJUSTMENTS, BUT THE DEVICE WAS NOT WORKING. THE DEVICE HAD NOT BEEN USED BY PATIENT. PATIENT WAS EXPERIENCING 'LOST OF URINE.' THE DEVICE WAS ON PROGRAM 4 AT 4.9 VOLTS BUT PATIENT DID NOT FEEL ANY STIMULATION. STIMULATOR SEEMED TO BE OFF. WHEN THE ON BUTTON WAS PRESSED AND STIMULATION INCREASED TO 8.0 VOLTS, PATIENT FELT THE STIMULATION COMFORTABLY. IT WAS LATER REPORTED THAT PATIENT EXPERIENCED REOCCURRENCE OF SYMPTOMS, PARTICULARLY LEAKING. THE DEVICE WAS ON PROGRAM 4 AT 8.5 VOLTS, BUT IT DID NOT DO ANYTHING. THEN IT WAS ADJUSTED TO PROGRAM 1 AT 2.8 VOLTS. A WEEK LATER, THE DEVICE WAS ADJUSTED TO 4.9 AND PATIENT WAS NOT COMFORTABLE. THE ISSUES HAD STARTED 4 OR 5 MONTHS AGO. PATIENT HAD GONE TO THE DOCTOR 4 TO 5 TIMES IN THAT TIME FRAME TO BE REPROGRAMMED. PATIENT WAS ON NEW MEDICATION. THE STIMULATION WAS DECREASED TO 4.7 VOLTS AND THEN TO 4.5 VOLTS. PATIENT WAS FINE AND COULD FEEL THE STIMULATION SLIGHTLY. LATER PATIENT EXPERIENCED PAIN IN THE 'PERINEAL AREA' SINCE SHE CHANGED IT. THE DEVICE WAS WORKING IN PROGRAM 1 AT 4.5 VOLTS ABOUT 1.5 WEEKS AGO. BEFORE PROGRAM 1, PATIENT WAS IN PROGRAM 4 AND IT DID NOT WORK. PATIENT HAD LEAKING OCCURRING AGAIN AND WENT TO EMERGENCY ROOM ABOUT A WEEK AGO BECAUSE HER LEGS FELT LIKE THEY WERE PARALYZED. NEUROLOGIST DETERMINED IT WAS FROM THE DRUG (ABILIFY) THAT PATIENT WAS TAKING. PATIENT WAS NOW IN A NURSING HOME FOR REHABILITATION. IT WAS NOTED THAT THE DEVICE HAD ALWAYS WORKED SLIGHTLY AND PATIENT ONLY HAD SLIGHT LEAKING. THE PROGRAMMER DID NOT SEEM TO WORK THE BEST; ADJUSTMENT COULD NOT BE MADE WITH ANTENNA ATTACHED. FOLLOW-UP INFORMATION RECEIVED REPORTED THAT THE CAUSE OF EVENT WAS UNKNOWN. PATIENT HAD DEMENTIA AND PATIENT OUTCOME WAS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1