BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4173973 · Received October 15, 2014

    Report

    Report Number
    3004209178-2014-19734
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 20, 2014
    Report Date
    September 23, 2014
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-33, LOT# V701764, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND HAD NO STIMULATION SENSATION. THE PATIENT HAD INCONTINENCE THAT STARTED 3 DAYS AGO WHEN THEY NOTICED THEY WERE GETTING UP AT NIGHT AND COULD NOT MAKE IT TO THE BATHROOM. THE PATIENT DIDN¿T RECALL WHEN THEY LAST HAD STIMULATION SENSATION AND THE PATIENT PROGRAMMER STOPPED WORKING TODAY. THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION AND SAW THE POOR COMMUNICATION SCREEN AND THE SWITCH POSITION WAS ASSESSED. THE PATIENT WAS ABLE TO GET THE PROGRAMMER TO WORK AND GOT TO THE MAIN SCREEN AND WAS ON ¿LEVEL 3¿ AT 7.5V AND THE STIMULATION WAS ON. THE PATIENT WAS ABLE TO INCREASE STIMULATION BUT REACHED THE HIGHEST AMOUNT AND SWITCHED TO PROGRAM 4 AND STARTED FEELING STIMULATION AT 4.9V. THE MANUFACTURER REPRESENTATIVE TOLD THE PATIENT TO CHANGE PROGRAMS IF INCONTINENCE HAD STARTED AND THEY HAD CYCLING PROGRAMMED. THE PATIENT ALSO NOTICED THE THIRD MIDDLE ICON ON THE PROGRAMMER OF THE LOW BATTERY ICON THAT MEANT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS LOW. NO OUTCOME OR INTERVENTIONS WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT MET WITH A MANUFACTURE REPRESENTATIVE FOR PROGRAMMING WHEN THEY DISCOVERED A HIGH AMPLITUDE ISSUE. THE PATIENT¿S SYSTEM WAS REPLACED BECAUSE THE PATIENT WAS USING HIGH AMPLITUDES AND WANTED TO REPOSITION THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656011 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention