BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 2153452 · Received June 21, 2011

    Report

    Report Number
    3004209178-2011-04646
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Report Date
    May 26, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING IMPLANT OF AN ACTIVA PC NEUROSTIMULATOR TO REPLACE A KINETRA IMPLANTABLE NEUROSTIMULATOR, THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. ALL SETTINGS FOR THE ACTIVE PC REMAINED AS THEY WERE WITH THE KINETRA. IT WAS REPORTED THAT AFTER THE REPLACEMENT, THE PATIENT DID NOT CHANGE CLINICALLY WHEN THE DEVICE WAS ON OR OFF. THERE WAS A SHORT WITH 4/7 WITH KINETRA PRIOR TO EXPLANT. ON (B)(6) 2011, IT WAS REPORTED THAT THE DEVICE HAS BEEN REPROGRAMMED AND THAT THE PATIENT WAS ALMOST BACK TO BASELINE. THE PATIENT WAS ABLE TO STAND, WALK, AND WAS SPEAKING WITH REDUCED TREMOR. IT WAS REPORTED THAT ELECTRODE IMPEDANCE WAS REVIEWED; 4/7 HAD LOW IMPEDANCE AT 59 OHMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387S, LOT# V159776| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU186696V| PROGRAMMER: MODEL 37642, LOT# NJZ109765N| EXTENSION: MODEL 7482A51, LOT# NHU186533V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387S, LOT# V159776