BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3915729 · Received July 7, 2014

    Report

    Report Number
    3004209178-2014-12582
    Event Type
    Injury
    Date Received
    July 7, 2014
    Report Date
    June 11, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3889-28, LOT# V388290, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) FOR HYPERTENSION AND EXTREME HEADACHES. IT WAS STATED THEY WERE BLAMING THE HEADACHES ON THE DEVICE. IT WAS NOTED WHEN THE PATIENT¿S STIMULATION WAS TURNED FROM 1 TO 4 VOLTS THEY HAD HEADACHES WITH THE HIGH VOLTAGE. IT WAS STATED WITHIN 20 MINUTES THE HEADACHES WENT AWAY AND THEY WERE NOT SURE WHEN THE HEADACHES STARTED. IT WAS NOTED A CT SCAN WAS DONE OF THE PATIENT¿S ABDOMEN AND BUTTOCKS. IT WAS LATER REPORTED IT WAS UNKNOWN IF THE PATIENT HAD A 50 PERCENT OR GREATER SYMPTOM REDUCTION. IT WAS STATED AN IMPEDANCE TEST WAS DONE ON (B)(6) 2014. IT WAS STATED THE DEVICE HAD IMPEDANCES GREATER THAN 4000 OHMS ON CASE AND 1, 0 AND 1, 2 AND 1, AND 3 AND 1. IT WAS NOTED ALL OTHER COMBINATIONS WERE LESS THAN 4000 OHMS. REPORTEDLY, THEY USED PROGRAM COMBINATIONS WITHOUT USING ELECTRODE 1. IT WAS STATED IT WAS UNKNOWN IF THE CAUSE OF THE EVENT WAS DETERMINED AND IF IT WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393630 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R