BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4737948 · Received April 29, 2015

    Report

    Report Number
    3004209178-2015-08171
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Report Date
    April 6, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 889-28, LOT# V252847, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT¿S IMPLANT WASN'T WORKING AND SHE HAD NEVER HAD THERAPEUTIC EFFECT. THE IMPLANT HADN'T WORKED FOR A COUPLE OF YEARS, BUT THE REPORTER DIDN'T KNOW HOW LONG IT HADN'T WORKED. THE PATIENT WAS HAVING A LOT OF PROBLEMS WITH INCONTINENCE AND WAS ON DIURETICS. SHE HAD LOST HER PATIENT PROGRAMMER, SHE HAD AN APPOINTMENT WITH HER DOCTOR FOR REPROGRAMMING AND TROUBLESHOOTING OF THE IMPLANT, AND THE DOCTOR'S OFFICE WANTED HER TO HAVE A PROGRAMMER TO BE SET UP. NO INTERVENTIONS OR OUTCOME WERE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282635 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1