BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3041561 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04895
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    August 28, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: 3387S-40 LOT# V030671, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3387S-40 LOT# V030671, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION. (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED,THE PATIENT WAS NOT HAVING CONCERNS WITH THEIR DEVICE OR THERAPY. IT WAS ALSO REPORTED, THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT THEY WERE WORKING WITH THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A SHOCKING OR JOLTING SENSATION. THE PATIENT REPORTEDLY FEELS "A LITTLE SHOCK" WHEN HE MOVES HIS ARM. IT IS UNCLEAR IF THE PATIENT WAS REFERRING TO HIS RIGHT OR LEFT ARM. IT WAS ALSO NOTED THAT THE PATIENT WAS NOT FEELING STIMULATION OR GETTING SYMPTOM RELIEF BUT IT WAS THEN STATED THAT HE HAS NOT HAD A RETURN OF SYMPTOMS. IT IS UNCLEAR IF THE PATIENT IS GETTING THERAPEUTIC EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143067 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1