BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5738572 · Received June 21, 2016

    Report

    Report Number
    3004209178-2016-12610
    Event Type
    Malfunction
    Date Received
    June 21, 2016
    Date of Event
    January 12, 2016
    Report Date
    June 21, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387S-40, LOT# V902308, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT SHE WAS WORRIED ABOUT HER LEAD AND BATTERY AT THE SPOT WHERE THEY CONNECTED BECAUSE SHE KEPT GETTING POOR COMMUNICATION. SHE COULD FEEL THE LEAD WIRE RUNNING UP HER NECK AND THE IMPLANT WAS STICKING OUT BECAUSE SHE WAS SKINNY. SHE HAS AN APPOINTMENT COMING UP IN ANOTHER WEEK OR TWO WITH HCP AND WOULD TRY TO MOVE IT UP. THE INDICATIONS FOR USE FOR THIS PATIENT WERE ESSENTIAL TREMOR AND MOVEMENT DISORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392783 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR