BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4783938 · Received May 20, 2015

    Report

    Report Number
    3004209178-2015-09419
    Event Type
    Malfunction
    Date Received
    May 20, 2015
    Report Date
    May 1, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 3889-28, LOT# V840299, IMPLANTED: (B)(6) 2012, 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 IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT WORKING. THE THERAPY HAD NOT BEEN WORKING FOR A WHILE. THE HEALTH CARE PROFESSIONAL (HCP) HAD THE IMPRESSION THAT THE PATIENT DID NOT UNDERSTAND THE THERAPY WELL. THE PATIENT HAD TALKED ABOUT GETTING THE IMPLANT REMOVED AND WOULD BE MEETING WITH HER MANAGING UROLOGIST. IT WAS REPORTED THAT THE PATIENT HAD BACK PAIN THAT MAY HAVE STARTED ABOUT A YEAR AGO OR AROUND THE TIME OF THE IMPLANT. NO INTERVENTIONS OR OUTCOME WERE 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
    329527 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1