BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2926143 · Received January 23, 2013

    Report

    Report Number
    3004209178-2013-00858
    Event Type
    Injury
    Date Received
    January 23, 2013
    Report Date
    August 5, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 64002, LOT# N259814, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: ADAPTER: PRODUCT ID 3387S-40, LOT# V175480, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 3387S-40, LOT# V175480, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEVELOPED AN INFECTION. THE LEADS AND EXTENSION WERE REMOVED IN (B)(6) 2012, BUT THE STIMULATOR WAS STILL IN THE PATIENT. THE PATIENT WAS SCHEDULED TO HAVE A HEAD MRI. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32788 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention