BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3394792 · Received October 8, 2013

    Report

    Report Number
    3004209178-2013-17644
    Event Type
    Malfunction
    Date Received
    October 8, 2013
    Report Date
    September 16, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3093-28, LOT# V192314, IMPLANTED: 2009-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT STATED THE IMPLANT WAS NOT WORKING AT THE TIME OF REPORT AND THAT HAD BEEN THE CASE FOR YEARS. IT WAS STATED THE REASON WHY IT WAS NOT WORKING WAS UNKNOWN AND THE PATIENT STATED THEY FELL AND MAY HAVE MESSED UP THE LEADS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510113 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1