BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2890734 · Received December 31, 2012

    Report

    Report Number
    3004209178-2012-12384
    Event Type
    Injury
    Date Received
    December 31, 2012
    Date of Event
    December 2, 2012
    Report Date
    December 7, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708660 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708660 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3389S-40 LOT# VA04ST0, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3389S-40 LOT# V975264, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED POST-OPERATIVE TRANSIENT CONFUSION AND HAD DIFFICULTIES WITH SPEECH. IT WAS STATED THERE WERE NO PRODUCT QUALITY ISSUES. THE PATIENT WAS READMITTED TO THE IMPLANTING HOSPITAL. IT WAS INDICATED, THE PATIENT WAS LATER DISCHARGED AND WAS "DOING WELL." THE PATIENT'S STATUS WAS LISTED AS NO INJURY. REFER TO MANUFACTURER REPORT #3004209178-2012-12383. THE PATIENT HAS TWO SYSTEMS AND IT WAS UNCLEAR IF ONE SYSTEM OR BOTH RELATED TO THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization