BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3571930 · Received January 13, 2014

    Report

    Report Number
    3004209178-2014-00608
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Report Date
    December 23, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V841549, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANT WAS TURNED OFF AT THE TIME OF THE REPORT BECAUSE, IT WAS NOT FUNCTIONING AND SHE GOT VERY SICK. THE PATIENT TURNED HER DEVICE OFF THREE MONTHS PRIOR TO THE REPORT WHEN SHE BECAME ILL WITH DIVERTICULITIS. THE PATIENT NEEDED A MRI FOR HER BRAIN AND WAS SEEING A NEUROLOGIST FOR HANDS AND FEET NUMBNESS. THE MRI WAS NOT RELATED TO THE DEVICE OR THERAPY. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30872 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1