BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4111381 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17569
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    September 1, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA0AWZE, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD HARDLY URINATE LAST TUESDAY, BUT BY WEDNESDAY HE COULDN'T. THE PATIENT WAS CURRENTLY USING A BAG NOW. THE PATIENT HAD TRIED TO INCREASE STIM. UP TO 6.9 OR 7.9 BUT COULD NOT FEEL STIM. THE PATIENT HAD A GRAND MAL SEIZURE 1-2 WEEKS AGO, HE FELL AND ENDED UP IN THE HOSPITAL. THE PATIENT HAS AN APPOINTMENT WITH HCP (HEALTHCARE PROVIDER) THIS WEDNESDAY AND HE WOULD LIKE A MANUFACTURER'S REPRESENTATIVE TO BE AT THE APPOINTMENT. SYMPTOMS REPORTED HAD SUDDEN ONSET. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589594 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| R