BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 2031538 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02117
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 28, 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

    THE BATTERY DEPLETED AND REACHED EOS AFTER ONE MONTH OF IMPLANT. THE IMPEDANCE MEASUREMENT FOR ELECTRODES 0 AND 1 WAS 38 OHMS. THE DEVICE WAS REPLACED. THE PT RECOVERED WITHOUT SEQUELA.

    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 73 YR Required Intervention EXPLANTED:| EXPLANTED:| ADAPTER: MODEL 64002, LOT# N259705| EXPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU149325V| LEAD: MODEL 3387S, LOT# V022472| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387S, LOT# V022472| EXPLANTED:| STIM ACCESSORY: MODEL PLUG/IPG, LOT# UNK| EXPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ107282N| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU149328V| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED: