BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 8015174 · Received October 29, 2018

    Report

    Report Number
    3004209178-2018-24115
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Report Date
    November 2, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169864191
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION FOR DATE OF EVENT. 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

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT WAS TO HAVE A PRE-OP MRI FOR A SECOND LEAD PLACEMENT. CALLER PERFORMED IMPEDANCE TEST AND FOUND LOW IMPEDANCES 250 OHMS. IT WAS REVIEWED THAT AN MRI WOULD NOT BE RECOMMENDED. NO SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED WITH THIS EVENT. VALUES REPORTED: C0=554 C1=539 C2=562 C3=1561 01=141 02=243 03=1602 12=182 13=1575 23=1541

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH THE HEALTHCARE PROVIDER (HCP) WAS MADE AWARE OF, REPORTED THEY FOUND THE LOW IMPEDANCES WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS INTERROGATED PRIOR TO A BRAIN MRI. THE MRI WAS CANCELLED, AND IMPEDANCES WERE CHECKED AGAIN ON OCTOBER 29TH AND THE ONLY LOW WAS FOUND WITH BIPOLAR 0-1 AT 212. THERE WERE NO INTERVENTIONS PLANNED AT THIS TIME AS THE PATIENT CONTINUED TO HAVE GOOD EFFICACY WITH EXISTING PROGRAMMING. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854338 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169864191

    Patients

    Seq Age Sex Outcome Treatment
    1