BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA SC

    MDR report key: 2251119 · Received September 8, 2011

    Report

    Report Number
    3004209178-2011-07565
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 30, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SEE MFR REPORT#: 3004209178-2011-07566. IT WAS ORIGINALLY REPORTED THAT FOR THE LAST SIX WEEKS THE PT EXPERIENCED TINGLING SENSATIONS IN HIS RIGHT ARM AND LEG WHEN HE BENDS OVER OR REACHES ABOVE HIS RIGHT ARM. THE TINGLING SENSATION WAS PROGRESSIVELY GETTING BETTER WITH TIME. THE THERAPY WAS WORKING WELL FOR HIS TREMOR SYMPTOMS. THE IMPEDANCE MEASUREMENTS WERE NORMAL. THE HEALTH CARE PROVIDER CONFIRMED THAT THE CAUSE OF THE EVENT WAS UNK. THERE WERE HIGH IMPEDANCE MEASUREMENTS. NO HOSPITALIZATION WAS REQUIRED. THE PT OUTCOME WAS NOTED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA SC MHY MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU036898V| EXPLANTED:| IMPLANTED:| LOT# NLA700522H| IMPLANTABLE NEURO STIMULATOR: MODEL 37602| EXPLANTED:| LEAD: MODEL 3389, LOT# J0406242V| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3389, LOT# J0406242V