BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4156073 · Received October 9, 2014

    Report

    Report Number
    3004209178-2014-18594
    Event Type
    Injury
    Date Received
    October 9, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-28, LOT# VA0FW05, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS A LITTLE CONCERNED ABOUT THEIR PROGRAMMER. THE PROGRAMMER HAD RECENTLY STARTED SHUTTING OFF IN THE NIGHT. THE PATIENT NOTED THAT AS SOON AS THEY PRESSED ¿STIMULATION ON¿ ON THEIR PROGRAMMER THEY COULD FEEL THE STIMULATION. THE PATIENT NEVER TURNED THEIR STIMULATION OFF EXCEPT WHEN THEY WENT TO THE DOCTOR OR THE DENTIST. THE PATIENT NOTED THAT IF THEY TURNED THEIR STIMULATION UP TOO HIGH IT HURTS. THE PATIENT USED TO HAVE THEIR STIMULATION AT 2.2, BUT AT THE TIME OF THE REPORT THEY COULD ONLY HAVE IT AT 1.7V. IF THEIR STIMULATION WAS HIGHER THAN 1.7V IT WAS PAINFUL AND UNCOMFORTABLE. THE PATIENT DIDN¿T ALWAYS MAKE IT TO THE BATHROOM WITH STIMULATION AT 1.7V. STARTING ABOUT A MONTH PRIOR TO THE REPORT, THE PATIENT STARTED HAVING TO GO TO THE BATHROOM AT 2 AM AND 6 AM EVERY NIGHT. FOR A LONG TIME THE PATIENT DIDN¿T HAVE TO GET UP AT NIGHT. THIS CHANGE STARTED ABOUT A MO NTH PRIOR TO THE REPORT. THE PATIENT HAD BAD DIARRHEA ABOUT A MONTH PRIOR TO THE REPORT DUE TO A BACTERIAL INFECTION AND THEY WERE GIVEN ANTIBIOTICS AND THE INFECTION CLEARED UP. THE PATIENT HAD THEIR DEVICE PROGRAMMED 2 WEEKS AFTER IMPLANT AND THEY DIDN¿T HAVE TO CHANGE ANYTHING UNTIL ABOUT A MONTH PRIOR TO THE REPORT. THERE WERE NO FALLS OR TRAUMA REPORTED WITH THE EVENT. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636503 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention