BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5181932 · Received October 27, 2015

    Report

    Report Number
    3004209178-2015-21604
    Event Type
    Injury
    Date Received
    October 27, 2015
    Report Date
    October 2, 2015
    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 Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-33, LOT# V021931, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED A BURNING SENSATION IN HER BUTTOCKS ON THE MORNING OF (B)(6) 2015 WHEN A NURSE HELPED THE PATIENT SWITCH TO PROGRAM 2 AT 1.40V. IT STARTED 2 WEEKS PRIOR TO THE REPORT WHEN THE PATIENT WAS GOING EVERY 20-25 MINUTES. THE PHARMACIST NOTED THAT SEROQUEL CAUSED THE FREQUENT URINATION. THE PATIENT SWITCHED TO VIIBRYD AND SHE WAS PUT ON PROGRAM 1 WHICH CAUSED THE PATIENT TO HAVE URINARY RETENTION. THE PATIENT ENDED UP IN THE EMERGENCY ROOM ON THE DAY OF (B)(6) 2015 FOR URINARY RETENTION. THE PATIENT WAS AT 1.40V AND IT WAS DECREASED TO 1.0V BUT IT COULD NOT GO DOWN FURTHER. PATIENT SERVICES HELPED THE PATIENT TURN THERAPY OFF. THE PATIENT COULD NOT TELL IF THE BURNING SENSATION WENT AWAY AFTER THERAPY WAS TURNED OFF; SHE HAD ICE ON HER BUTTOCKS. THE PATIENT WAS INDICATED FOR GASTROINTESTINAL/ PELVIC FLOOR. NO FURTHER INFORMATION WAS PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712615 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other