BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6735889 · Received July 24, 2017

    Report

    Report Number
    3004209178-2017-15380
    Event Type
    Malfunction
    Date Received
    July 24, 2017
    Report Date
    August 11, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    UDI-DI
    00613994934604
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387S-40, LOT# V091117, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V090726, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 HEALTHCARE PROVIDER ABOUT A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT STARTED EXPERIENCING TINGLING IN THEIR LEFT FACE AND HAND. THE PATIENT ALSO HAD NUMBNESS IN THEIR LEFT HAND. IT WAS STATED THAT THE PATIENT WAS ALSO DIZZY. THESE ISSUE BEGAN 2-3 WEEKS PRIOR. IT WAS SUSPECTED THAT THE REPORTED SYMPTOMS WERE CAUSED BY LEAD MIGRATION. THEY WERE WAITING ON COMPARISON WITH OLD MRI FOR CONFIRMATION. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515746 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601 00613994934604

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR