BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4424096 · Received January 15, 2015

    Report

    Report Number
    3004209178-2015-00804
    Event Type
    Injury
    Date Received
    January 15, 2015
    Date of Event
    September 8, 2009
    Report Date
    December 26, 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 MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V295465, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3889-41, LOT# V062662, IMPLANTED: (B)(6) 2009, 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 DEVICE TRIAL WORKED, BUT WITH THE PERMANENT DEVICES, THERAPY DID NOT HELP THE PATIENT TO EMPTY HER BLADDER AT LEAST 70 PERCENT. THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND HAD TO SELF-CATHETERIZE ON A REGULAR BASIS. THE PATIENT¿S DEVICES WERE REMOVED SOMETIME IN 2010. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. SEE MFR. REPORT #3004209178-2015-00801 FOR INFORMATION REGARDING THE PATIENT¿S OTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36143 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention