BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3070840 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06640
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    April 5, 2013
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A REPLACEMENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) ON (B)(6) 2013 THE IMPEDANCE VALUE FOR CONTACT #2 WAS "ABNORMALLY INCREASED" OVER 40,000 OHMS. IT WAS STATED THAT BECAUSE "THE SITE HAD BEEN STIMULATED, RIGIDITY WAS AGGRAVATED". IT WAS UNCERTAIN WHAT THAT MEANT. IT WAS NOTED THAT THE STIMULATION CONTACT WAS CHANGED AND THE PATIENT CONDITION WAS "SLIGHTLY ALLEVIATED". IT WAS REPORTED THAT BECAUSE THE ISSUE OCCURRED AFTER THE INS WAS REPLACED, A PRODUCT FAILURE WAS SUSPECTED. THE IMPEDANCE SOON AFTER REPLACEMENT WAS 1700 OHMS. TWO WEEKS LATER, IT WAS 7000 OHMS AND THREE WEEKS LATER, IT WAS GREATER THAN 40,0000 OHMS. ON (B)(6) 2013, IT WAS STATED THAT THE PATIENT COMPLAINED OF NOT BEING ABOUT TO MOVE THEIR RIGHT ARM WITH IMPEDANCE AT 9200 OHMS. ON (B)(6) 2013, THE IMPEDANCE VALUE FOR THE 0-2 CIRCUIT WAS GREATER THAN 40,0000 OHMS. IT WAS REPORTED THAT THE INS WAS GOING TO BE EXPLANTED AND CHECKED "WITHIN DAYS". IT WAS STATED THAT IT WAS A POSSIBILITY THAT A SCREW WAS LOOSE BETWEEN THE INS AND THE EXTENSION. IT WAS ALSO A POSSIBILITY THAT THERE WAS A FRACTURE TO THE LEAD OR EXTENSION, OR AN INS FAILURE. THOSE POSSIBILITIES WERE GOING TO BE EXPLORED. FURTHER INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT AN OPERATION WAS CONDUCTED TO CONFIRM SCREWS. AFTER THE SCREWS OTHER THAN 2ND SCREW THAT CORRESPONDED TO 2ND ELECTRODE OF IPG SIDE WERE LOOSENED, THE IPG WAS DISCONNECTED FROM THE EXTENSION; IT WAS CONFIRMED THAT THE 2ND SCREW HAD BEEN LOOSE. AFTER THE SCREWS WERE TIGHTENED UP, IMPEDANCE WAS MEASURED. CONTACT 2 SHOWED AN IMPEDANCE OF 886O, AND ¿ENERGIZATION¿ WAS CONFIRMED. THE PROCEDURE WAS ENDED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPEDANCE HAD BEEN ¿GOOD¿ AND ¿GOT NORMAL¿ AFTER TIGHTEN THE SECOND ELECTRODE SCREW. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. IMPLANTABLE PULSE GENERATOR WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172442 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention