BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3783281 · Received May 1, 2014

    Report

    Report Number
    3004209178-2014-08331
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Report Date
    April 9, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-33, LOT# VA0886M, IMPLANTED: (B)(6) 2013, 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 THIS REPORTER WAS NOTIFIED THE DAY BEFORE REGARDING A POR (POWER ON RESET) CONDITION. THE MESSAGE APPEARED FOLLOWING EMI (ELECTROMAGNETIC INTERFERENCE) EXPOSURE. PER CARETAKER, IT WAS NOTED AFTER A CARDIO-VERSION. THE DATE OF EVENT FOR CARDIO-VERSION WAS UNKNOWN. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT CAME TO THE DOCTOR'S OFFICE ON (B)(6) 2014 FOR REPROGRAMMING. THE POR MESSAGE WAS EASILY CLEARED AND 4 NEW PROGRAMS WERE PUT INTO 3037 (THE PROGRAMMER). THE PATIENT LEFT WITH ISSUE RESOLVED AND FEELING STIMULATION APPROPRIATELY. NO FURTHER INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263630 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1