BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3593400 · Received January 27, 2014

    Report

    Report Number
    3004209178-2014-01221
    Event Type
    Injury
    Date Received
    January 27, 2014
    Date of Event
    January 6, 2014
    Report Date
    January 7, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3389S-40, LOT# V991333, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3389S-40, LOT# V991333, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THERE WAS A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED, THE PATIENT WASN¿T GETTING THE SAME QUALITY OF RELIEF AS WHEN THEY WERE FIRST IMPLANTED BACK IN (B)(6) 2013. IT WAS NOTED IT WAS UNDETERMINED WHAT THE EXACT CAUSE OF THE ISSUE OR EVIDENCE THAT THERE WAS A SYSTEM ISSUE. IT WAS NOTED SURGICAL REVISION TOOK PLACE ONE DAY PRIOR TO REPORT. IT WAS NOTED THE HEALTH CARE PROFESSIONAL REMOVED THE EXTENSIONS AND IMPLANTED NEW ONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59932 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention