BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3647337 · Received February 26, 2014

    Report

    Report Number
    3004209178-2014-03601
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Report Date
    January 28, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# V811041, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    ABOUT THREE WEEKS PRIOR, IT WAS REPORTED THE PATIENT WANTED TO MAKE SURE THE INTERSTIM WAS WORKING CORRECTLY BECAUSE THEY AND THEIR DOCTOR WERE CONSIDERING REMOVING THE DEVICE. THE PATIENT WANTED TO GIVE THE DEVICE EVERY OPPORTUNITY TO ASSIST THEM WITH THEIR CONDITION. THE PATIENT HAD PAIN AT THE IMPLANT SITE FOR THE LAST 3-4 MONTHS. IT WAS THOUGHT TO BE THE IMPLANTABLE NEUROSTIMULATOR SITE. STIMULATION HAD BEEN TURNED OFF SINCE (B)(6) 2013 SINCE IT DID NOT PROVIDE THE PATIENT WITH URINARY RELIEF. THE PATIENT WANTED THE MANUFACTURER REPRESENTATIVE¿S OPINION. ALMOST TWO WEEKS LATER, IT WAS NOTED THE PATIENT HAD MET WITH THEIR REPRESENTATIVE AND ADJUSTMENTS WERE MADE TO THE DEVICE. THE PATIENT WAS TO INFORM THE REPRESENTATIVE HOW MANY TIMES THEY WENT TO THE BATHROOM AND HOW THEY WERE DOING. INFORMATION RECEIVED AS OF THE DATE OF THIS REPORT INDICATED THE PATIENT DID FEEL STIMULATION, BUT IT WAS UNCLEAR TO WHERE IT WAS FELT. AN IMPEDANCE CHECK REVEALED THAT TWO OF THE ELECTRODES WERE ¿NOT FUNCTIONING PROPERLY.¿ THE REPRESENTATIVE REPROGRAMMED AROUND THE ELECTRODES, BUT FELT THAT A REVISION WAS NEEDED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118553 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Male