BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 2093642 · Received May 12, 2011

    Report

    Report Number
    3004209178-2011-03453
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    January 5, 2011
    Report Date
    April 19, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEAD HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IN MFR REPORT # 3004209178-2010-10688: IT WAS REPORTED THERE WERE HIGH IMPEDANCES AND THE STIMULATOR WAS REPLACED. FOLLOWING THE REPLACEMENT THE DEVICE CONTINUED TO HAVE HIGH IMPEDANCE MEASUREMENTS. THE IMPEDANCE LEVELS RANGED FROM ABOUT 800-4500 OHMS. THE EXTENSION WAS REPLACED ON (B)(6) 2011. FOLLOWING THE EXTENSION REPLACEMENT, THE IMPEDANCES LEVELS WERE STILL HIGH. THE LEVELS RANGED FROM 1102-13965 OHMS. THE THERAPEUTIC EFFECT DID NOT IMPROVE AFTER THE STIMULATOR AND EXTENSION REPLACEMENT. THE LEAD WAS REPLACED ABOUT 2 WEEKS AFTER THE EXTENSION HAD BEEN REPLACED. THE PT WAS DOING "MUCH BETTER" AFTER THE LEAD REPLACEMENT. THE IMPEDANCE LEVELS APPEARED TO HAVE NORMALIZED. THE PT WAS STILL SEEKING A BETTER OUTCOME THOUGH.

    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 72 YR Required Intervention EXPLANTED:| LEAD: MODEL 3387, LOT# V127417| IMPLANTED:| IMPLANTABLE NEUROM STIMULATOR: MODEL 7428,| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ106981N| IMPLANTED:| LOT# NFD109160H| EXTENSION: MODEL 7482A51, LOT# NHU180486V| EXTENSION: MODEL 37085, LOT# NKN012964V| PROGRAMMER: MODEL 7436, LOT# NFU020504P| EXPLANTED:| ADAPTER: MODEL 64002, LOT# N256797| EXPLANTED:| IMPLANTED: