BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4334110 · Received December 16, 2014

    Report

    Report Number
    3004209178-2014-24056
    Event Type
    Injury
    Date Received
    December 16, 2014
    Report Date
    November 24, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37612, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3387S-40, LOT# V011138, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 64001, LOT# N251181, IMPLANTED: 2011 (B)(6); PRODUCT TYPE ADAPTER PRODUCT ID 3387-40, LOT# J0214131V, IMPLANTED: 2002 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7495LZ66, SERIAL# (B)(4), IMPLANTED: 2002 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 64001, LOT# N251185, IMPLANTED: 2011 (B)(6); PRODUCT TYPE ADAPTER PRODUCT ID 37612, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD ONE INSTANCE OF A STAPH INFECTION AND HAD TO HAVE THEIR IMPLANTABLE NEUROSTIMULATORS (INS) REMOVED. NO INTERVENTIONS OR OUTCOME WERE 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
    824300 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention