BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE LEAD

    MDR report key: 2914514 · Received January 14, 2013

    Report

    Report Number
    3007566237-2013-00177
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE SEIZURES OCCURRED WHEN THE SECOND LEAD WAS ATTEMPTED TO BE INSERTED. IT WAS NOTED THE PATIENT WAS UNRESPONSIVE FOR A CERTAIN "TIME PERIOD." IT WAS INDICATED THE LEAD HIT A "WRONG NERVE" WHICH CAUSED THE PATIENT'S SEIZURE EXPERIENCE. IN ADDITION, THE PATIENT WAS GIVEN AN INJECTION TO "FIGHT OFF" THE PATIENT'S REACTION TO LIDOCAINE. IT WAS STATED THE PATIENT DID NOT LEAVE THE EMERGENCY ROOM FOR ABOUT FOUR HOURS. THE PATIENT WAS "INCOHERENT," HAD FACIAL TWITCHING AND WAS MOANING/GROANING. THE PATIENT WAS INFORMED THE PHYSICIAN HAD MADE A MISTAKE AND THE PATIENT ONLY RECEIVED 1% LIDOCAINE. THE PATIENT'S DISCHARGE PAPERS SAY 1%, HOWEVER A NURSE AT THE PHYSICIAN'S OFFICE STATED THE PATIENT RECEIVED 2% LIDOCAINE. IT WAS ULTIMATELY UNCLEAR WHAT PERCENTAGE OF LIDOCAINE THE PATIENT RECEIVED. IT WAS INDICATED THE PATIENT WAS FEELING "MUCH BETTER" WHEN THEY HAD THEIR FOLLOW UP APPOINTMENT WITH THE PHYSICIAN. AT THAT TIME, THE PATIENT DID NOT WANT TO MOVE FORWARD WITH THE FULL IMPLANT AND THE PHYSICIAN REMOVED THE LEAD FROM THE PATIENT'S TAILBONE, WITH "LITTLE PAIN" FELT BY THE PATIENT. A SECOND FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD SEIZURES DURING THE TRIAL. IT WAS STATED THAT ONE LEAD WAS IMPLANTED AND THEN "SEIZURES CAME ON." THE NURSING STAFF CAME INTO THE OPERATING ROOM TO TEND TO THE PATIENT. IT WAS UNCLEAR IF THE LEAD REMAINED IN THE PATIENT, OR IF IT WAS REMOVED WHEN THE SEIZURES BEGAN. IT WAS INDICATED THE SEIZURES WERE POSSIBLY DUE TO THE PHYSICIAN'S USE OF 2% LIDOCAINE. THE PATIENT WAS ADMITTED TO THE HOSPITAL. LATER, THE PATIENT WAS REPORTED TO BE "UP AND WALKING AROUND" AT THE HOSPITAL AND WAS PLANNED TO BE RELEASED AS OF THE DATE OF THIS REPORT. FOUR DAYS LATER, IT WAS REPORTED THAT NO TEST LEAD WAS IMPLANTED. THE CAUSE OF THE EVENT WAS DUE TO LIDOCAINE TOXICITY. 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
    20390 IMPLANTABLE LEAD STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O