BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2914438 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-00572
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Report Date
    December 28, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V861091, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD EXPERIENCED A SHOCKING OR JOLTING SENSATION AFTER THE IMPLANT WHEN SHE HAD LEFT THE HOSPITAL. IT WAS STATED THAT THE PATIENT WAS FINE AFTER A HEALTHCARE PROFESSIONAL SHOWED HER HOW TO TURN THE STIMULATION DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20038 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1