BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7511720 · Received May 14, 2018

    Report

    Report Number
    3004209178-2018-10836
    Event Type
    Injury
    Date Received
    May 14, 2018
    Date of Event
    February 1, 2018
    Report Date
    May 14, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    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 THE CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT HAD TO TURN THE STIMULATION UP AFTER IMPLANT BECAUSE THEY FELT LIKE THEY WERE HAVING TO USE THE BATHROOM MORE FREQUENTLY. THEY WENT IN FOR A FOLLOW UP APPOINTMENT AND SAW THE NURSE PRACTIONER (NP) WHO NOTED THE ¿NUMBERS WERE TOO HIGH¿. THEY SWITCHED THE PATIENT FROM PROGRAM 4 TO PROGRAM 1 BUT THEY WERE STILL HAVING URINARY FREQUENCY AND WANTED ASSISTANCE IN MAKING AN ADJUSTMENT. THE PROGRAMMER SHOWED THAT THE STIMULATION WAS ON, ON PROGRAM 1 AT 2.2 VOLTS. THE PATIENT STATED THAT THEY DID NOT THINK IT WAS RIGHT FOR THE NP TO SAY THE ¿NUMBER WAS TOO HIGH¿ AND WANTED TO TURN IT UP BECAUSE IT WAS NOT HELPING. THE STIMULATION WAS INCREASED ON PROGRAM 1 TO 2.8 VOLTS AND FELT THE STIMULATION IN THE CORRECT BIKE SEAT AREA. THE PATIENT WAS GOING TO MONITOR THEIR SYMPTOMS WITH THE CHANGE MADE AND WILL FOLLOW UP WITH THE HEALTHCARE PROFESSIONAL (HCP) IF THE ISSUE DID NOT RESOLVE. ON (B)(6) 2018, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER. THE PATIENT DID NOT WANT TO GO TO THE HCP BECAUSE OF CO-PAYS AND BEING ON A FIXED INCOME. THE PATIENT HAD BEEN PRESSING PROGRAMMER NAVIGATION BUT TONS AND WANTED TO CHECK THAT SHE DIDN'T MESS ANYTHING UP. THE SETTING WAS CURRENTLY AT PROGRAM 2 ON 4.4 VOLTS. THE PATIENT WAS PUT ON MEDICATION THAT CAN CAUSE FREQUENT URINATION. THE PATIENT WAS STILL HAVING URINARY LEAKAGE (STATES SHE WAS SITTING ON A CHAIR AND PEED HERSELF WHEN SHE STOOD UP). THE PATIENT STATES SHE DOESN'T KNOW IF THIS URINATION IS DUE TO THE NEW MEDICATION OR THE STIMULATOR STILL NOT HELPING. PATIENT IS FEELING REALLY FRUSTRATED BECAUSE SHE DOESN'T KNOW WHAT TO DO. PATIENT SERVICES REDIRECTED THE PATIENT TO THEIR HCP AND RECOMMENDED SHE CONTINUE TO DO WHAT SHE IS DOING, TRYING NEW SETTINGS, MONITORING SYMPTOMS TO SEE IF THAT HELPS. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED. ON (B)(6) 2018 MORE INFORMATION WAS RECEIVED FROM PATIENT CONTINUING TO REPORT THEY WEREN'T EXPERIENCING IMPROVED SYMPTOM CONTROL AND HAVING RETURNED OF SYMPTOMS. THEY THOUGHT THEY HAD A URINARY TRACT INFECTION (UTI) AND WENT TO THE EMERGENCY ROOM. THEY HAD SOME SIMPLE TESTING DONE AND WAS TOLD THEY DIDN'T HAVE IT. PATIENT WASN'T CONVINCED DUE TO THE SYMPTOMS OF BURNING AND BLOOD IN URINE SO THEY WENT TO THE HEALTHCARE PROFESSIONAL (HCP) OFFICE AND ANOTHER TEST WAS DONE. PATIENT JUST RECEIVED A PHONE ALL A FEW DAYS AGO CONFIRMING THAT THEY HAD A UTI. THEY HAVE NOW BEEN ON 2 DAYS OF ANTI-BIOTICS. THEY HAVE GONE BACK TO THE HCP OFFICE, AND THE PA INCREASED THEIR SETTING ON CHANNEL AND TOLD THEM TO STAY ON THIS CHANNEL AS LONG AS THEY WERE EXPERIENCING SYMPTOMS RESULTS. DURING THE CALL, PATIENT HAD ACCESS TO THEIR PATIENT PROGRAMMER. THEY SYNCED WITH THE PATIENT PROGRAMMER AND SHOWED STIM WAS ON, AND THEY HAD THE ABILITY TO ADJUST STIMULATION. IT WAS REVIEWED WITH PATIENT TO COMPLETE A VOIDING DIARY AND TRACK PROGRESSION/THERAPEUTIC RESPONSE. IT WAS ALSO REVIEWED THAT WHILE ON ANTI-BIOTICS, THE RESULTS MAY NOT BE AS ACCURATE. PATIENT WAS TOLD TO CONTINUE THEIR ANTI-BIOTIC TREATMENT FOR THE ACTIVE UTI, AND ONCE INFECTION WAS CLEARED UP, THEY CAN REASSESS SYMPTOMS AND MAKE ADJUSTMENTS. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353771 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other