BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3551199 · Received January 3, 2014

    Report

    Report Number
    3004209178-2014-00138
    Event Type
    Malfunction
    Date Received
    January 3, 2014
    Report Date
    December 12, 2013
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 3 093-33, LOT# V941222, IMPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TRYING TO CHANGE THE PROGRAM ON HER DEVICE, WASN¿T FEELING ANY STIMULATION AND NEEDED TO MAKE IT HIGHER, DIDN¿T ¿KNOW HOW TO DO IT,¿ AND WAS HAVING DIFFICULTY UNDERSTANDING THE ¿BOOK THAT WAS GIVEN TO HER.¿ IT WAS NOTED THAT THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION, WHICH RESOLVED AFTER THE PATIENT WAS GIVEN INSTRUCTIONS. IT WAS REPORTED THAT THE PATIENT WAS ON PROGRAM 2 AT 1.3 VOLTS WITH THE ¿LIGHTNING BOLT.¿ IT WAS NOTED THAT BEFORE AT NIGHT THE PATIENT COULD FEEL STIMULATION AND NOT SO MUCH DURING THE DAY BECAUSE HER MIND WAS ¿BUSY.¿ IT WAS REPORTED THAT THE DAY PRIOR TO THE REPORT AND THE DAY OF THE REPORT THE PATIENT WASN¿T FEELING THE STIMULATION. IT WAS NOTED THAT THE PATIENT WENT UP TO 1.4 VOLTS AND ¿FELT THAT LITTLE JOLT.¿ IT WAS REPORTED THAT THE PATIENT ADJUSTED THE DEVICE UP TO 1.5 VOLTS AND STATED THAT IT FELT LIKE IT DID WHEN SHE WAS DOING THE TRIAL. THE PATIENT WAS STANDING AFTER MAKING THE ADJUSTMENT AND THE PATIENT TRIED SITTING AND SAID THAT STIMULATION WAS MILD. IT WAS REPORTED THAT THE PATIENT WANTED TO LEAVE STIMULATION THERE TO SEE HOW IT DOES. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3399 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR