BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3802369 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08780
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    April 18, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 889-28, LOT# J0421412V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S HEALTHCARE PROVIDER TOLD THEM THEY HAD A WIRE THAT WAS NOT RIGHT AND ONE OF THE ¿WIRES¿ MAY BE COMPROMISED. IT WAS STATED THE PATIENT WAS INFORMED OF THIS FOLLOWING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT SURGERY. THE PATIENT STATED THEY HAD ¿3 WIRES¿ AND THE HEALTHCARE PROVIDER ¿GOT A BEEP FROM THE FIRST AND SECOND ONES BUT NOTHING FROM THE THIRD WIRE.¿ IT WAS NOTED THE PATIENT MAY BE TALKING ABOUT THEIR ELECTRODES BUT IT WAS UNCLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281412 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR