BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3143479 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08578
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 14, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT# V513773, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BEING SHOCKED WHEN SHE INCREASED STIMULATION AND THAT THE DEVICE HAD NOT BEEN WORKING/CONTROLLING HER SYMPTOMS SINCE THE PATIENT WAS IN THE HOSPITAL BACK IN (B)(6). AT THAT TIME, THE PATIENT¿S DEVICE WAS TURNED OFF AND IT WAS OFF PRIOR TO NOW. THE PATIENT WAS CURRENTLY ON PROGRAM 4 AT 4.7 V, WAS ABLE TO DECREASE TO 3.4 V, STIMULATION WAS COMFORTABLE AND FELT IT IN THE LEFT HIP AREA, WHERE THE DEVICE WAS IMPLANTED. IT WAS NOTED THAT THE PATIENT DID NOT RECALL WHEN THIS STARTED, BUT THOUGHT IT WAS DURING THE TIME OF THE (B)(6) HOSPITALIZATION. IT WAS NOTED THAT PATIENT WAS NOT SURE IF SHE WAS GETTING 50% REDUCTION IN SYMPTOMS. WHEN THE PATIENT WOULD STAND UP, THE URINE WOULD GUSH, AND WHEN SHE INCREASED STIMULATION TO 4.7 V, THE PATIENT FELT STIMULATION IN HER BICYCLE AREA, BUT UNCOMFORTABLE STIMULATION. SUBSEQUENT INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH HER DEVICE/THERAPY, BUT WAS WORKING WITH HER DOCTOR/MANUFACTURER REPRESENTATIVE WITH APPOINTMENT DATES NOTED AS (B)(6) 2013 WITH HER PHYSICIAN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WHEN RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PICTURE OF THE DEVICE WITH A QUESTION MARK ON THE PROGRAMMER SCREEN. THE PATIENT FELT PAIN WHEN THEY INCREASED STIMULATION. IT WAS NOTED THAT THE PATIENT ONLY FELT STIMULATION IN THE RECTAL AREA WHEN THE STIMULATION WAS REALLY STRONG AT 4.7 V. IT WAS NOTED THAT THE STIMULATION WAS TURNED OFF WHEN THE PATIENT WAS IN THE HOSPITAL AND THAT ONE TIME THE BATTERY IN THE PROGRAMMER WENT DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243187 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1