BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4375638 · Received December 31, 2014

    Report

    Report Number
    3004209178-2014-24739
    Event Type
    Malfunction
    Date Received
    December 31, 2014
    Report Date
    December 10, 2014
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT # V972376, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37603, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389S-40, LOT # V972376, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37603, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELT A ¿PRICKLY¿ FEELING TODAY WHILE THEY HAD UROPLASTY DONE WITH ELECTRODES PLACED ON THEIR ANKLE. THE PATIENT FELT THE SENSATION IN THEIR BRAIN, BUT IT COULD HAVE BEEN THEIR SCALP. THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS OFF FOR THE THERAPY. IN THE PAST THE PATIENT HAD STIMULATION ON AND THEY FELT THE SAME FEELING SO THEY STARTED TO TURN STIMULATION OFF. THE PATIENT WONDERED WHY THEY FELT THE SENSATION WITH THE INS OFF. 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
    861962 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1