BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3112370 · Received May 14, 2013

    Report

    Report Number
    3007566237-2013-01612
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    May 2, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387-40, LOT# J0309504V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT# J0309504V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED INTERMITTENT STIMULATION. IT WAS STATED THAT WHEN THE PATIENT MOVED HER LEFT ARM ACROSS HER BODY, WHICH MOVED THE IMPLANTABLE NEUROSTIMULATOR (INS), SHE GOT A ¿TINGLY ZAPPY¿ FEELING DOWN HER RIGHT ARM. IT WAS ADDED THIS WAS SIMILAR TO WHAT SHE FELT WHEN SHE TURNED THE INS OFF AND BACK ON, BUT ¿NOT QUITE AS SEVERE.¿ IT WAS NOTED THE PATIENT HAD A ¿WHOOSHY¿ FEELING IN HER HEAD. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213221 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37602

    Patients

    Seq Age Sex Outcome Treatment
    1