BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4041054 · Received August 27, 2014

    Report

    Report Number
    3004209178-2014-15974
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Report Date
    August 4, 2014
    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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# VA081H7, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NO STIMULATION SENSATION. IT WAS NOTED SINCE REPLACING BATTERIES IN CONTROLLER A COUPLE WEEKS AGO, BEFOREHAND THE PATIENT SAID THAT SHE FELT STIMULATION. THE PATIENT REPORTS A LOSS OF THERAPEUTIC EFFECT A COUPLE WEEKS AGO. SYMPTOMS REPORTED HAD SUDDEN ONSET. THE PATIENT INDICATES THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. THE PATIENT WENT TO CHECK HER DEVICE AFTER THE ACCIDENT AND TURNS OUT SHE HAD TO REPLACE BATTERIES IN PATIENT PROGRAMMER AND SHE THOUGHT THAT WAS THE REASON FOR RETURN OF SYMPTOMS. NO FALLS, TRAUMA OR NEW ACTIVITIES. THE PATIENT HAD TRIED ALL OF THE PROGRAMS AND ADJUSTED SOME HOWEVER HESITANT ABOUT INCREASING TOO HIGH SINCE SHE DOESN'T FEEL STIMULATION. THE PATIENT CAN'T REMEMBER WHICH PROGRAM SHE WAS ON BEFORE REPLACING THE BATTERIES. CURRENTLY THE PATIENT WAS ON PROGRAM 2 AT 3.5 VOLTS ADD STIMULATION WAS ON. THE PATIENT SAID SHE HASN'T BEEN BACK TO HCP (HEALTHCARE PROVIDER) SINCE RECEIVING THIS IMPLANT IN (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521434 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR