BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3232833 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11941
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    May 10, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 889-28, LOT# VA04M45, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AMPLITUDE DROPPED FROM 3.2 TO 2.4 ¿ON IT'S OWN.¿ IT WAS NOTED THAT THIS OCCURRED THE TWO WEEKS PRIOR TO THE DATE OF THIS REPORT. THE PATIENT CHECKED ON THE DATE OF THIS REPORT AND NOTICED THE 2.4. THE PATIENT THEN INCREASED TO 2.5. THE PATIENT PLANNED TO MONITOR FOR CHANGES IN AMPLITUDE. THE PATIENT MAY CONTACT THE MANUFACTURING REPRESENTATIVE FOR POSSIBLE REPROGRAMMING. IT WAS NOTED THE BATTERY ICON ON THE TOP ROW OF THE PATIENT PROGRAMMER WAS ¿HALFWAY GONE.¿ ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333240 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR