BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5883242 · Received August 17, 2016

    Report

    Report Number
    3004209178-2016-17040
    Event Type
    Injury
    Date Received
    August 17, 2016
    Date of Event
    January 4, 2016
    Report Date
    August 17, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: EXTENSION. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# V851358, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID 3387S-40, LOT# V857736, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A MANUFACTURER REPRESENTATIVE (REP) STATED A PATIENT CAME IN WITH INFECTED LEADS AND EXTENSION AND REQUIRED REPLACEMENT ON THOSE DEVICES. THE PATIENT IS IMPLANTED FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534295 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R