BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 4482882 · Received February 4, 2015

    Report

    Report Number
    3004209178-2015-01704
    Event Type
    Malfunction
    Date Received
    February 4, 2015
    Report Date
    January 12, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-28, LOT# J0546487V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PROBLEM WITH THE PATIENT PROGRAMMER . THE PATIENT REPORTS NOT BEING ABLE TO MAKE ADJUSTMENT BOTH WITH OR WITHOUT ANTENNA ATTACHED. HE NOTICED ISSUE THE DAY BEFORE REPORTED EVENT DATE WHEN HE WASN'T ABLE TO COMMUNICATE WHEN HE WAS TRYING TO INCREASE STIMULATION. THE PROGRAMMER WON'T DO TELEMETRY WITH OR WITHOUT ANTENNA. NO PATIENT HARM WAS REPORTED. IT WAS LATER REPORTED DURING PREVIOUS CALL, THE PATIENT HAD REPORTED NOT BEING ABLE TO ADJUST WITH OR WITHOUT THE ANTENNA. HE GOT THE REPLACEMENT CONTROLLER TODAY. PATIENT SERVICE HAD THE PATIENT TRY TO USE THE REPLACEMENT CONTROLLER WITH AND WITHOUT ANTENNA, AND WAS STILL GETTING THE POOR COMMUNICATION SCREEN. UPON RETURN OF THE PROGRAMMER, DURING ANALYSIS, THE SOFTWARE WAS UPDATED TO VERSION 1.4 PER ECO 09-01338. REPLACED THE DIRTY LENS. REPLACED THE TARNISHED ANTENNA JACK AS PREVENTIVE MEASURE. THE COMPLAINT WAS UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82696 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR