BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2870203 · Received December 12, 2012

    Report

    Report Number
    3004209178-2012-11743
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    November 23, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT # V038042, IMPLANTED: (B)(64) 2007, 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. IT WAS STATED THAT THE PATIENT'S THERAPY WAS WORKING "FINE" AND "EVERY SO OFTEN" SHE HAD TO ADJUST IT. IT WAS REPORTED THAT ABOUT TWO MONTHS THE PATIENT TURNED IT UP. THE PATIENT STATED THAT SHE URINATES "A LOT" AND HAS TO URINATE 2-3 TIMES A NIGHT. IT WAS ALSO STATED THAT THE PATIENT COULD NOT FEEL STIMULATION. IT WAS REPORTED THAT THE PATIENT STARTED HAVING "NERVE BLOCKS" DONE AROUND THE SAME TIME (2 MONTHS AGO). IT WAS REPORTED THAT THE HEALTH CARE PROVIDER (HCP) USES AN X-RAY TO "FIND WHERE TO PUT THE STEROID INSIDE" TO BLOCK THE PAIN FROM A FALL THAT HAPPENED IN 2004. THE HCP "REMOVED" THE FRACTURE IN 2004 AND THE FOLLOWING YEAR THE PATIENT WAS IMPLANTED WITH THE STIMULATOR. IT WAS STATED THAT THE PROGRAMMER WAS WORKING "FINE" AND THE PATIENT COULD HEAR IT "BEEPING." IT WAS STATED THAT THE PATIENT WAS "NOT VERY HEAVY" AND THE PROGRAMMER WAS ABLE TO COMMUNICATE WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS STATED THAT THE AREA AROUND THE INS DOES NOT HURT UNLESS IT IS BUMPED. IT WAS STATED THAT THE PATIENT WAS COGNITIVE OF HER IMPLANT ON THE LEFT SIDE. THE PATIENT WAS ON PROGRAM 4 AT 2.8 VOLTS. IT WAS NOTED THAT THE PATIENT COULD NOT FEEL ANY STIMULATION. IN THE PAST THE PATIENT WAS ABLE TO FEEL WHEN STIMULATION WAS INCREASED OR DECREASED. IT WAS STATED THAT THE PATIENT WAS URINATING IN HER PANTS DUE TO STIMULATION NOT BEING HIGH ENOUGH. THE PATIENT CHANGED TO PROGRAM 4 A WEEK AGO. THE PATIENT TURNED STIMULATION OFF AND ALL THE PROGRAMS TO 0.0 V. THEN PATIENT TURNED TO PROGRAM 3 AND SLOWLY INCREASED STIMULATION TO 5.8 V. IT WAS STATED THAT THE PATIENT COULD FEEL A "MILD" SENSATION. IT WAS INCREASE TO 6.0 V AND THE FELT STIMULATION "LIGHT AND STEADY." THE PATIENT LEFT IT AT THAT SETTING TO SEE IF IT WOULD HELP HER SYMPTOMS. FURTHER INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1