BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4377243 · Received January 2, 2015

    Report

    Report Number
    3004209178-2015-00003
    Event Type
    Injury
    Date Received
    January 2, 2015
    Report Date
    December 8, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 64002, LOT # N380689, IMPLANTED: (B)(6) 2013, PRODUCT TYPE ADAPTER; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3389-40, LOT # J0537708V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 3389-40, LOT # J0537727V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 3389-40, LOT # J0537708V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 3389-40, LOT # J0537727V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO CORRECT.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE NEUROSTIMULATOR, SERIAL #(B)(4), FOUND IT FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES. ANALYSIS OF THE EXTENSION, SERIAL #(B)(4), FOUND ITS OUTER INSULATION HAD A BREACHED DEPRESSION. THE #2 CONDUCTOR WAS THUS EXPOSED 31.7 CENTIMETERS FORM THE DISTAL END. ANALYSIS OF THE LEADS, LOT #J0537708V AND #J0537727V, FOUND THE OUTER INSULATION HAD MULTIPLE BREACHED LOCATIONS AND ESC.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS GOING TO HAVE A LEAD REPOSITION IN ABOUT ONE WEEK AND THEREFORE THEY WERE GOING TO HAVE AN MRI DONE. THE MANUFACTURER REPRESENTATIVE HAD TO CHECK THE DEVICE BEFORE THE MRI AND ELECTRODE IMPEDANCE WAS TAKEN AT 0.7V. THE RESULTS WERE C0: 4087 OHMS, 02: 4467 OHMS, 03: 5189 OHMS. REPORTS INCREASED TO 3V: C0: 3746 OHMS, 02: 4067 OHMS, 03: 4593 OHMS. THE UNIPOLAR PAIRS WERE WITHIN RANGE AND TESTED AT 0.7V: C1: 1418 OHMS, C2: 1306 OHMS, C3: 1684 OHMS. IT WAS UNKNOWN WHY THE PATIENT WAS HAVING THE LEAD REPOSITION. NO INTERVENTIONS OR OUTCOME 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 WENT TO HAVE A MRI IN (B)(6) 2014 AND TRIED TO TURN OFF THE STIMULATION WITH HER PROGRAMMER, BUT THE PROGRAMMER BATTERIES WERE DEAD. THE MANUFACTURER REPRESENTATIVE (REP) CAME TO THE MRI FACILITY AND CHECKED THE IMPEDANCES ON THE LEADS AND TOLD THE PATIENT THE NUMBERS WERE WRONG AND WOULD NOT LET HER TURN OFF THE STIMULATION. THE MRI WAS CANCELLED AND SHE WAS SCHEDULED FOR SURGERY TO REPLACE THE LEAD. THE PATIENT'S ENTIRE SYSTEM WAS REMOVED AND REPLACED ON (B)(6) 2014 OR (B)(6) 2015; SHE WAS NOT SURE WHICH DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention