BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2875224 · Received December 17, 2012

    Report

    Report Number
    3004209178-2012-11891
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Report Date
    June 1, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V576606, IMPLANTED: (B)(6) 2010, 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 A PATIENT EXPERIENCED A LOSS OF THERAPY AND THE ELECTRODES HAD HIGH IMPEDANCES. IT WAS STATED THAT THERE WAS NO STIMULATION SENSATION AND THE PATIENT HAD AN INCREASE IN 'BASELINE PAIN' AS WELL AS 'MORE AND MORE FLARES.' IT WAS NOTED THAT THE PATIENT COULD LAST FEEL STIMULATION 'ABOUT 2 MONTHS AGO.' THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. THE PATIENT WAS ON PROGRAM 3 AND TURNED UP STIMULATION TO 8.5V AND STILL DID NOT FEEL STIMULATION WHETHER STANDING OR SITTING. IT WAS STATED THAT PROGRAM 4 WAS TOO PAINFUL FOR THE PATIENT WHEN SHE TRIED IT 'A WHILE AGO' AND DID NOT TRY IT AGAIN. IT WAS STATED THAT THE PATIENT WAS ON PROGRAM 1 'FOR A LONG TIME' AT 2.0V AND INCREASED TO 2.6 V. THEN THE PATIENT CHANGED TO A DIFFERENT PROGRAM BECAUSE 'SHE THOUGHT MAYBE THE NERVE WAS TIRED.' APPROXIMATELY 6 MONTHS LATER IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT ABOUT 2 WEEKS AFTER BEING REPROGRAMMED ON 4 NEW PROGRAMS IN (B)(6). IT WAS STATED THAT THE PATIENT DID NOT ADJUST AMPLITUDE OR CHANGE PROGRAMS DURING THAT TIME AND THAT THERAPY HAD WORKED DURING THAT TIME. AT THAT TIME ALL THE IMPEDANCE MEASUREMENTS WERE GREATER THE 4000 OHMS. IT WAS STATED THAT THE ELECTRODE CONFIGURATION WHEN THERAPY WAS LOST WAS 2-,3-,C+ AND THE USAGE WAS 100%. THE ONLY IMPEDANCES IN RANGE WERE C2=1280 OHMS, C3=1768 OHMS, 23= 3540 OHMS; TESTING AT DEFAULT PARAMETERS OF 2.0V AND 330 PULSE WIDTH. X-RAYS WERE TAKEN AND EVERY THING 'LOOKED IN PLACE' WITH NO ABNORMALITIES. THE PATIENT WAS REPROGRAMMED TO 4 NEW PROGRAMS THAT DAY WHICH WERE: P1 C+ 3-, P2 2-, 3+/P3 2- 3- C+/ P4 3- 2+. TWO DAYS LATER IT WAS REPORTED THAT THE PATIENT COULD FEEL ALL 4 PROGRAMS VAGINALLY AND THE PROGRAMS WERE UNDER 3.0V. THE PATIENT WAS GOING TO CALL THE COMPANY REPRESENTATIVE IN 2 WEEKS IF SYMPTOMS DID NOT IMPROVE. NO FURTHER INFORMATION WAS PROVIDED. MORE INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    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