BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5391388 · Received January 26, 2016

    Report

    Report Number
    3004209178-2016-01050
    Event Type
    Injury
    Date Received
    January 26, 2016
    Date of Event
    January 3, 2016
    Report Date
    January 3, 2016
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389S-40, LOT# V984593, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID 3389S-40, LOT# V884064, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE MANUFACTURER'S REPRESENTATIVE REPORTED THAT THE PATIENT SCRATCHED THEIR HEAD AND DEVELOPED AN INFECTION. NO DIAGNOSTICS OR TROUBLESHOOTING WERE PERFORMED. THE DEEP BRAIN STIMULATOR (DBS) SYSTEM WAS EXPLANTED ON THE DAY OF THIS REPORT. THE PATIENT WAS NOT TO SEEK A REPLACEMENT FOR THE DEVICE AS THEY NO LONGER NEEDED THE THERAPY. THE ISSUE WAS CONSIDERED AS RESOLVED AT THE TIME OF THIS REPORT. THE INDICATIONS FOR USE FOR THIS PATIENT WERE PARKINSON'S DUAL AND MOVEMENT DISORDERS. THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS NOTED AS "ALIVE - NO INJURY". IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48893 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention