BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5730344 · Received June 16, 2016

    Report

    Report Number
    3004209178-2016-12377
    Event Type
    Malfunction
    Date Received
    June 16, 2016
    Report Date
    June 16, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3389S-40, LOT# VA0KSWZ, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# VA0KS5H, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A MANUFACTURING REPRESENTATIVE REPORTED IMPEDANCE WERE TESTED AT 1.5V AND CAME BACK HIGH. IMPEDANCE RAN AT 3V AND IMPEDANCE THEN CAME BACK NORMAL. IMPEDANCE CHANGED WHEN THE PATIENT WAS IN BOTH THE SITTING AND SUPINE POSITIONS; HIGH IMPEDANCE WHILE SITTING, NORMAL IMPEDANCE WHEN IN SUPINE. THE PATIENT WAS IN THE OPERATING ROOM GETTING READY FOR A REPLACEMENT OF A NEW IMPLANTABLE NEUROSTIMULATOR (INS) WHICH HAD BEEN SCHEDULED TO BE EXPLANTED AS IT WAS AT END OF LIFE. CHECK OF THE LEAD INDEPENDENT OF THE SYSTEM WAS REQUESTED WHILE PATIENT WAS IN SURGERY. ENTIRE SYSTEM WAS CHECKED, ELECTRODE IMPEDANCE CHECK AND LOW IMPEDANCE WHEN JUST THE LEAD WAS CHECKED. AN X-RAY WAS DONE AND THE HEALTHCARE PROFESSIONAL WANTED TO KNOW IF THERE WAS BARIUM IN THE BOOT. PATIENT WAS NOT GETTING SYMPTOM CONTROLLED. NO PATIENT SYMPTOMS REPORTED. PATIENT'S INDICATION FOR USE IS MOVEMENT DISORDERS. THE EVENTS HAD CONFIRMED WHAT HAD BEEN OBSERVED IN THE CLINIC BY THE PATIENT'S NEUROLOGIST. C/0-935, C/1-967, C/2-1053, C/3-977, 0/1-1358, 0/2-1864, 0/3-1722, 1/2-1554, 1/3-1654 AND 2/3-1398. C/8-1204, C/9-1119, C/10-830, C/11-910, 8/9-1793, 8/10-1596, 8/11-1781, 9/10-1353, 9/11-1715, AND 10/11-969

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384159 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1