BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 5064947 · Received September 9, 2015

    Report

    Report Number
    3004209178-2015-17598
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Date of Event
    May 13, 2009
    Report Date
    August 13, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    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# V237346, IMPLANTED: (B)(6) 2009. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4)

    Description of Event or Problem · 1

    NOTIFICATION MESSAGE FROM GCH (GLOBAL COMPLAINT HANDLING) REPORTS THE STIMULATOR WAS IMPLANTED PAST EXPIRATION DATE. THE PATIENT WAS DIAGNOSED WITH URINARY DYSFUNCTION/SACRAL NERVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595369 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR