BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2992587 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03439
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3 708660 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3387S-40 LOT# V835130, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3387S-40 LOT# V833493, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD HAD A RETURN OF SYMPTOMS FOLLOWING THE DEVICE BEING SHUT OFF. THE REPORTER STATED THAT MANUFACTURING REPRESENTATIVE HAD TURNED THE DEVICE BACK ON AND THE PATIENT WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT "ACCIDENTLY TURNED OFF" HER IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS FURTHER REPORTED THAT THE PATIENT WAS "ADMITTED TO THE HOSPITAL" FOLLOWING THIS INCIDENT. THE INCIDENT WAS REPORTED TO HAVE OCCURRED "ABOUT A MONTH" PRIOR TO REPORT. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF REPORT. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97961 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization