BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3930295 · Received July 11, 2014

    Report

    Report Number
    3004209178-2014-12935
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Report Date
    June 18, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT # VA0E6SH, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF THERAPEUTIC EFFECT, AT NIGHTTIME ONLY WHEN SHE WENT TO WATCH GRANDCHILD AT HER SON'S HOUSE 2-3 TIMES A WEEK. IT WAS INDICATED THAT IT OCCURRED SINCE MATCH .THE PATIENT SLEPT ¿ON AN AIR MATTRESS NEXT TO GARAGE DOOR OPENER.¿ SYMPTOMS REPORTED HAD SUDDEN ONSET ONLY WHEN WATCHING GRANDCHILD AT HER SON'S HOUSE OTHERWISE PATIENT STATED THAT SHE HAD SYMPTOM CONTROL 99% OF THE TIME. THE PATIENT STATED THAT AT THIS TIME SHE HAD NOT CHECKED HER DEVICE OR ADJUSTED STIMULATION WHEN SHE HAD EXPERIENCED RETURN OF SYMPTOMS WHILE AT HER SON'S HOUSE. IT WAS NOTED THAT PATIENT RECEIVED ASSISTANCE FROM THEIR MANUFACTURER REPRESENTATIVE AND HER CONCERNS WERE RESOLVED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405962 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR