BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4102981 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17415
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    June 20, 2014
    Report Date
    August 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE (NEUROSTIMULATOR) (NJY256510H) REVEALED FUNCTIONALLY OKAY/INSIGNIFICANT ANOMALIES.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-28, LOT# VA0KA5J, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTS THE PHYSICIAN RECLOSED THE WOUND AND IT WAS FINE. PATIENT'S THERAPY WAS WORKING AND WOUND SEEMED TO BE HEALING. SINCE THEN THE HEALTHCARE PROVIDER DECIDED TO REMOVE THE LEAD AND BATTERY. WHEN THE PATIENT CAME BACK IN FOR ANOTHER CHECK-UP THE WOUND STILL WAS OPENED AND IT APPEARED RED AND POSSIBLY INFECTED. THE HEALTHCARE PROVIDER REMOVED THE LEAD AND BATTERY ON (B)(6) 2014 AND REPLACED IT WITH A NEW LEAD AND BATTERY. PATIENT HAS BEEN SEEN SINCE AND WAS DOING GREAT. INCISION HAS HEALED AND SHE WAS RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S IMPLANT INCISION NEVER HEALED RIGHT. THE INCISION DID NOT COMPLETELY CLOSE AND THE BATTERY COULD BE SEEN WHEN YOU LOOKED AT THE INCISION CLOSELY. IT WAS BELIEVED TO BE DUE TO THE PATIENT NOT FOLLOWING POST-SURGICAL ACTIVITY RESTRICTIONS AS THE PATIENT WAS PLAYING TENNIS AND GOLF. CULTURES WERE RUN AND IT WAS CONFIRMED THERE WAS NO INFECTION AT THE TIME. THE DOCTOR SUTURED THE OPENING TO ENSURE IT WAS CLOSED AND NO BATTERY WAS VISIBLE BENEATH THE SKIN. THE PATIENT WAS SEEING OVER A 50 PERCENT IMPROVEMENT AND WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583894 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention