BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3955012 · Received July 24, 2014

    Report

    Report Number
    3004209178-2014-13471
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    July 1, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3889-28, LOT# J0436980V, IMPLANTED: 2004 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REASON FOR THE CALL WAS THE LIGHTS ON THE BACK OF THE PATIENT PROGRAMMER WERE NOT COMING ON. THE PATIENT REPORTS NOT BEING ABLE TO ADJUST STIMULATION. THE STATUS LIGHTS WERE ASSESSED. THE PATIENT STATES, SHE WAS ONLY SEEING THE 9 VOLT BATTERY LIGHT ON THE PATIENT PROGRAMMER. THE PATIENT STATES THIS WEEK SHE NOTICED A RETURN OF SYMPTOMS. IT WAS REPORTED ALL OF A SUDDEN SHE HAS TO GO TO THE RESTROOM ALL THE TIME. THE PATIENT CHECKED HER INS (STIMULATOR) WITH THE PATIENT PROGRAMMER AND NOTICED THE INS ON LIGHT WAS NOT ON. THE PATIENT STATES 9 VOLT BATTERY ICON WAS GREEN AND THAT WAS THE ONLY LIGHT. THE PATIENT INQUIRED ABOUT LONGEVITY FOR BATTERIES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HEALTHCARE PROVIDER OR MANUFACTURER REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT APPOINTMENT WAS SCHEDULED FOR (B)(6) AND THIS WILL BE THEIR FIRST APPOINTMENT WITH HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434686 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR