BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3191352 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10932
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 5, 2013
    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 PRODUCTS: PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012; PRODUCT TYPE: EXTENSION; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387S-40, LOT# VA02S0T, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3387S-40, LOT# V975686, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT¿S LEADS WERE COMING THROUGH HER SKIN AS A RESULT OF SKIN EROSION. THE ENTIRE SYSTEM WAS GOING TO BE EXPLANTED ON (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE LEAD EROSION WAS NOT DETERMINED. IT WAS NOTED THAT THE DEVICE WAS EXPLANTED AND THE PATIENT WAS NOT REIMPLANTED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289935 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention