BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4243309 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21305
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    October 20, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 64001, LOT# N259654, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECENTLY HAD A REVISION ON (B)(6) 2014. THE PATIENT¿S THERAPY WAS NOT AS EFFECTIVE FOR THE PATIENT¿S TREMOR SO THEY MOVED THE LEAD TO SEE IF THAT WOULD BE MORE EFFECTIVE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725909 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention