BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3961470 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13590
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3389S-40, LOT# VA0JLR4, IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A MRI ON THE DAY OF THE REPORT AND FORGOT TO TURN HIS THERAPY OFF. THE PATIENT WANTED TO KNOW IF ANY DAMAGE WAS DONE. THE PATIENT STATED THAT HIS SPEECH WAS SLURRED, BUT IT WAS NORMAL AGAIN. THE PATIENT ALSO HAD A TINGLY FEELING IN HIS LEFT FOOT, BUT IT WAS ¿3/4 GONE NOW.¿ THE PATIENT¿S LEFT ARM WAS ALSO GOOD NOW. THE MRI WAS TO CHECK LEAD PLACEMENT. THE PATIENT¿S STATUS WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437824 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR