BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 2031511 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02122
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 28, 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 INS REACHED NORMAL BATTERY DEPLETION. THE IMPEDANCE MEASUREMENTS WERE HIGH. THE INS AND EXTENSIONS WERE 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 65 YR Required Intervention IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ104114N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# J0306891V| IMPLANTED:| LEAD: MODEL 3387, LOT# J0211549V| IMPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL PLUG/IPG, LOT# UNKNOWN| ADAPTER: MODEL 64002, LOT# UNKNOWN| EXPLANTED:| ADAPTER: MODEL 64001, LOT# UNKNOWN| EXPLANTED:| IMPLANTED:| ADAPTER: MODEL 64001, LOT# UNKNOWN| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU007175V| EXTENSION: MODEL 7482, LOT# NGK021560N| EXPLANTED: