BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 4503598 · Received February 10, 2015

    Report

    Report Number
    3004209178-2015-02741
    Event Type
    Malfunction
    Date Received
    February 10, 2015
    Report Date
    January 21, 2015
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-28, LOT# V800435, IMPLANTED: (B)(6) 2011, 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 THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT WAS WORKING WITH THEIR HEALTHCARE PROVIDER OR MANUFACTURER REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT SHOWED HIS HEALTHCARE PROVIDER A "CALL YOUR DOCTOR" ICON WITH A POWER ON RESET (POR) CONDITION ABOUT A WEEK PRIOR TO THE REPORT. IT WAS INDICATED HE WAS NOT ABLE TO ADJUST STIMULATION. THE PATIENT HAD A DOCTOR'S APPOINTMENT SET FOR (B)(6) 2015 THAT THE PATIENT WAS NOT ABLE TO MAKE. THE PATIENT WAS TO RESCHEDULE APPOINTMENT. NO SYMPTOMS, INTERVENTIONS, OR OUTCOME WAS PROVIDED REGARDING THIS EVENT, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL IN FORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98471 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1