BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7114633 · Received December 13, 2017

    Report

    Report Number
    3004209178-2017-25938
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Report Date
    January 8, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761071
    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

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THE DOCTOR ORDERED A CT SCAN AND CONSULT REQUEST WITH A DIFFERENT DOCTOR. THE CAUSE WAS NOT DETERMINED, BUT IT WAS NOTED THAT THE PATIENT RECENTLY FELL. THE PATIENT FIRST EXPERIENCED THE HIGH IMPEDANCE/DYSTONIA ON (B)(6) 2017. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT WAS IN THE EMERGENCY ROOM WITH INCREASED DYSKINESIA SYMPTOMS. THE PATIENT HAD HIGH IMPEDANCE. THEY WERE PROGRAMMED 1+ 2- 3-, AMPLITUDE 3.4 V, PULSE WIDTH 450 US, RATE 70 HZ. C <(>&<)> 0 3209 OHMS C <(>&<)> 1 >40000 C <(>&<)> 2 447 C <(>&<)> 3 695 0 <(>&<)> 1 >40000 0 <(>&<)> 2 3176 0 <(>&<)> 3 3536 1 <(>&<)> 2 >40000 1 <(>&<)> 3 >40000 2 <(>&<)> 3 704 IT WAS RECOMMENDED THE PATIENT BE PROGRAMMED ON CONTACTS WITHOUT HIGH IMPEDANCE. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892993 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603 00613994761071

    Patients

    Seq Age Sex Outcome Treatment
    1