BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3900310 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-12200
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 5, 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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 3889-28, LOT# V358329, IMPLANTED: 2009-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT STATED THAT THE ¿WHOLE THING SHUTS DOWN" AND SHE DID NOT FEEL STIMULATION AND IT BEGAN OVER A YEAR AGO. IT WAS INDICATED THAT BECAUSE OF THIS SHE JUST LEFT IT OFF AND WAS NOT USING IT AND STATED IT WAS "WASTE OF TIME TO EVEN HAVE THE IMPLANT ". IT WAS INDICATED THE PATIENT STILL HAD TROUBLE GOING TO THE BATHROOM AND SHE DID NOT THINK IT WAS WORKING RIGHT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT PATIENT APPOINTMENT WAS SCHEDULED FOUR AFTER THIS REPORT FOR REPROGRAMMING OF THE NEU ROSTIMULATOR. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376553 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR