BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3840477 · Received May 30, 2014

    Report

    Report Number
    3007566237-2014-01483
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 9, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_UNKNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID NEU_RECHARGER_ACC, SERIAL# UNKNOWN, PRODUCT TYPE RECHARGER; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AN IMPLANTABLE NEUROSTIMULATOR (INS) OVERDISCHARGE WAS SUSPECTED. IT WAS NOTED THE PATIENT HADN¿T CHARGED FOR OVER A YEAR. IT WAS FURTHER REPORTED IT WAS UNKNOWN WHEN THE PATIENT HAD NOTICED THE CHARGING HAD BECOME AN ISSUE. IT WAS STATED THE PATIENT DID NOT SEE THE BENEFIT OF THE SYSTEM AND DID NOT FEEL THAT IT WORKED. IT WAS STATED THE PATIENT HAD THE SYSTEM ONLY IMPLANTED ON ONE SIDE OF THE BRAIN. IT WAS NOTED THEY HAD CONSIDERED HAVING THE DEVICE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED REPORTED THE OVERDISCHARGE WAS CONFIRMED. IT WAS NOTED THE CAUSE OF THE OVERDISCHARGE WAS PATIENT COMPLIANCE. IT WAS NOTED THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY AT THE TIME OF REPORT. IT WAS NOTED IT WAS NOT TURNED ON AND THEY HAD NOT PLANNED TO TURN IT ON. IT WAS STATED THE PATIENT DID NOT WANT SURGERY OR A NEW BATTERY BECAUSE THEY DID NOT THINK IT HELPED SIGNIFICANTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319419 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37612

    Patients

    Seq Age Sex Outcome Treatment
    1