BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC+S

    MDR report key: 8055337 · Received November 9, 2018

    Report

    Report Number
    3004209178-2018-25092
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    November 1, 2018
    Report Date
    January 9, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL 37604 ACTIVA PC+S IS NOT A COMMERCIALLY MARKETED DEVICE, BUT IS SIMILAR TO MARKETED DEVICES AND THEREFORE IS REPORTABLE FOR MALFUNCTION. MHY AND P960009 ENTERED, AS THE DEVICE WAS IMPLANTED FOR ESSENTIAL TREMOR. 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 HEALTH CARE PROVIDER (HCP) OF A CLINICAL STUDY VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR. THE INS COULD NOT BE INTERROGATED. THE EVENT OCCURRED AFTER PREVIEWING RECORDINGS ON THE SENSING TABLET, STARTING A DOWNLOAD OF ALL THE DATE (SINGLE RUN), THE INS WAS ACCIDENTALLY INTERROGATED WITH THE PATIENT PROGRAMMER DURING THE DOWNLOAD SESSION, AND THE INS "LOCKED UP" IN UNDEFINED STATUS. THE INS COULD NOT BE INTERROGATED WITH THE SENSING TABLET, STIMULATION PROGRAMMER, NOR THE CLINICIAN PROGRAMMER. THE REP EXPLAINED HOW TO PERFORM A HARD POWER ON RESET (POR) ON THE INS, WHICH RESOLVED THE EVENT. NO MEDICAL SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895312 ACTIVA PC+S STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37604

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR