BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 4192957 · Received October 22, 2014

    Report

    Report Number
    3004209178-2014-20170
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Report Date
    September 29, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT# J0349213V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) HADN¿T WORKED FOR FIVE YEARS. IT WAS UNCLEAR IF THE INS WAS DEPLETED OR THERE WAS SOME OTHER ISSUE. NO SYMPTOMS, INTERVENTIONS, OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672399 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1