BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4851613 · Received June 17, 2015

    Report

    Report Number
    3004209178-2015-11789
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Report Date
    May 26, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V497081, IMPLANTED: (B)(6) 2010, 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 POWER-ON-RESET (POR) CONDITION WAS SEEN ON THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) AND THAT THEY WERE UNABLE TO ADJUST THE STIMULATION. THE PATIENT STATED THAT THEY HAD BEEN TO THE HOSPITAL FOR VARIOUS UNRELATED MEDICAL PROCEDURES AND FOR FOLLOW UP WHICH INCLUDED A COLONOSCOPY. IT WAS NOTED THAT THE STIMULATION WAS NO LONGER WORKING SINCE SEEING THE WARNING POR MESSAGE ON THE PROGRAMMER. THE PATIENT DENIED SEEING AN INFORMATIONAL POR PREVIOUS TO THIS WARNING POR CONDITION. ON FOLLOW UP, THE PATIENT REPORTED THEY RECEIVED ASSISTANCE FROM THEIR DOCTOR AND THE MANUFACTURER¿S REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. AN APPOINTMENT OF (B)(6) 2015 WAS NOTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394790 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR