BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 9214449 · Received October 21, 2019

    Report

    Report Number
    3004209178-2019-20029
    Event Type
    Injury
    Date Received
    October 21, 2019
    Date of Event
    January 1, 2019
    Report Date
    October 21, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    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 A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR PATIENT REPORTED THAT THEY EXPERIENCED A PAINFUL/UNCOMFORTABLE STIMULATION AFTER THEY FELL OUT OF THEIR CAR THIS WINTER ON THEIR INS SITE AND SINCE THE FALL, THEY HAD A RECTAL PAIN . PATIENT FURTHER REPORTED THAT THE DEVICE WAS FOR BLADDER BUT SHE STARTED EXPERIENCING TERRIBLE PAIN IN THEIR BUTTOCK AND THE PAIN OCCURRED WHEN STIMULATION WAS ON OR WHEN SHE INCREASE STIMULATION. THEY ALSO SAID THAT THE PAIN ALSO CAUSED A RECTAL DISCHARGE THAT HAD CAUSED TWO E. COLI INFECTIONS. CALLER STATES ON THE CALL THAT THE INFECTIONS WERE CAUSED FROM DRIPS FROM HER COLON AND URINE. CALLER STATES HER MOST CURRENT INFECTION WAS CONFIRMED ON (B)(6) 2019. CALLER MENTIONS SHE WAS HIGHLY ALLERGIC TO THE MEDICINE SO SHE HAS JUST BEEN TAKING BENADRYL AND A "DIFFERENT KIND OF ANTIBIOTIC." CALLER STATES THAT SHE WENT TO HER HCP OFFICE AND A MDT REP SWITCHED PROGRAMS ON HER DEVICE AND THAT HAS HELPED RESOLVE THE RECTUM PAIN. THEN, CALLER STATES THAT A MDT REP REPROGRAMMED HER AND SINCE SHE HAS HAD TO START CATHING ONCE A DAY AGAIN BECAUSE SHE STILL HAS SOME URINARY RETENTION AND THAT SHE DOES NOT LIKE CATHING. CALLER STATES THAT HER DEVICE IS ONLY AT 0.3V AND DOESN'T WANT TO INCREASE. CAL LER STATES THAT SHE IS NERVOUS HER MUSCLES "DOWN THERE" AREN'T WORKING AND NEEDS TO SEE HER HCP IN (B)(6), NO FURTHER COMPLICATIONS WERE NOTED OR ANTICIPATED SEE PE (B)(4) FOR ALREADY REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008411 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention