BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5532009 · Received March 29, 2016

    Report

    Report Number
    3004209178-2016-05563
    Event Type
    Malfunction
    Date Received
    March 29, 2016
    Date of Event
    March 1, 2016
    Report Date
    August 24, 2016
    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

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR INDICATION GASTROINTESTINAL/PELVIC. PATIENT HAD EXP ERIENCED A LOSS OR CHANGE OF THERAPY. HER TRIAL WAS AMAZING AND THE FIRST WEEK WITH THE PERMANENT IMPLANT WAS GREAT. HOWEVER, THE PATIENT HAD TWO, RECENT EPISODES, ONE MINOR AND THE OTHER WAS A 'MELTDOWN'. SHE DESCRIBED THE MELTDOWN AS HAVING NO CONTROL AND HER ST OOL WAS THE CONSISTENCY OF ICE TEA. SHE DOES FEEL STIMULATION. AFTER THE FIRST MINOR EPISODE, SHE INCREASED STIMULATION FROM 1.4 TO 1.5 V. THE PATIENT HAS FOLLOW-UP APPOINTMENT WITH HCP (HEALTHCARE PROVIDER) ON (B)(6) 2016. EVENT DATE ON (B)(6) 2016 FOR MINOR EPISODE AND (B)(6) 2016 FOR MELTDOWN/INCREASED STIMULATION TO 1.5 V.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT WHEN THE PATIENT HAD HER FIRST ACCIDENT ON (B)(6) 2016, ¿IT WAS LIKE IT WAS STARTING ALL OVER AGAIN.¿ YESTERDAY, (B)(6) 2016, WAS HORRIBLE. IT WAS AS BAD, IF NOT WORSE THAN BEFORE. YESTERDAY MORNING THE PATIENT WAS NOT FEELING THE VIBRATION SO SHE INCREASED IT UP ONE NOTCH, WHICH WAS WHAT SHE HAD BEEN USING. THEY PUT IT AT 1.4 AND SHE INCREASED IT UP TO 1.5, WHICH WAS WHAT SHE USED IN THE BEGINNING DURING THE TRIAL. THE PATIENT WAS ON HER WAY HOME WHEN SHE HAD VERY LITTLE WARNING AND IT WAS HORRIBLE. THE PATIENT NOTED THAT SHE USUALLY HAD NO WARNING. IT WAS NOT HELPING MUCH THEN WHEN COMPARED TO THE TRIAL. THE PATIENT ASKED IF THIS WERE TO HAPPEN AGAIN IF SHE SHOULD GO UP ON HIGHER. THE PATIENT WAS ADVISED TO GO A LITTLE BIT HIGHER AS LONG AS IT WAS COMFORTABLE. THE PATIENT DESCRIBED THE CONSISTENCY ¿LIKE CHOCOLATE MILK COMING OUT¿ AND THEN THIS TIME IT WAS LIKE ¿ICED TEA.¿ THE PATIENT HAD NO CONTROL. THE PATIENT HAD BEEN FEELING GOOD UP UNTIL (B)(6) AND THE WEEK BEFORE. ON THE DAY OF THE REPORT STIMULATION WAS STILL AT 1.5. THE PATIENT WAS NOT GOING TO THE BATHROOM AND USUALLY SHE WOULD GO 3 OR 4 TIMES. SHE HAD ¿ONLY BEEN 1, AND 1, AND 1 TODAY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186874 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR