BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2841800 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10613
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 24, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-33, LOT# VA01QGD, IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT THE EVENT 'STARTED NOT HELPING' ON (B)(6)-2012, AND GOT 'WORSE AND WORSE, ESPECIALLY AFTER LAST NIGHT.' IT WAS NOTED THAT THE PATIENT TRIED ALL 4 PROGRAMS AND THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE COMPLAINT. THE PATIENT REPORTEDLY HAD 'NO CONTROL ON HOLDING HER STOOL' AND WANTED TO SWITCH PROGRAMS TO SEE IF THAT WOULD HELP. IT WAS STATED THAT THE PATIENT WAS NOT SURE ABOUT THE LOCATION OF THE SYMPTOMS AND THAT THE PATIENT HAD AN APPOINTMENT ON (B)(6)-2012. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1