BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3002705 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03671
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 25, 2013
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V952171, IMPLANTED: (B)(6) 2012, PRODUCT TYPE :LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH HER DEVICE OR THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED NO STIMULATION AND A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT THE DEVICE WAS "TURNING OFF ON ITS OWN ON A REGULAR BASIS WHICH STARTED ABOUT 2 WEEKS" PRIOR TO THE REPORT. IT WAS NOTED THAT THE PATIENT WOULD RESET AND LEAVE THE DEVICE, BUT "THE NEXT THING [THE PATIENT] KNEW [SHE] WASN'T FEELING STIMULATION AND IT WOULD BE TURNED OFF". IT WAS FURTHER NOTED THAT THE PATIENT WOULD TURN THE STIMULATION BACK ON AND "20-30 MINUTES LATER SHE WOULD NOTICE THE PULSES HAD STOPPED AGAIN". THE PATIENT REPORTEDLY HAD NOT BEEN ABLE TO URINATE "VERY WELL" WITHIN THE LAST COUPLE OF WEEKS OF THE REPORT. IT WAS STATED THAT THE POOR COMMUNICATION SCREEN WAS DISPLAYED ON THE PATIENT PROGRAMMER. IT WAS NOTED THAT THE PATIENT PRESSED THE OFF KEY WHEN TRYING TO CHECK DEVICE ON/OFF STATUS "STATING SHE WAS PRESSING THE MIDDLE LEFT KEY" WHICH WAS THE STIMULATION OFF KEY. THE PATIENT REPORTEDLY WAS SCHEDULED TO MEET WITH THE HEALTHCARE PROVIDER THE FOLLOWING DAY. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104854 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR