BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 2031522 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02123
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    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). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MFR EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE. THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD THE SYS REPLACED DUE TO HIGH IMPEDANCE AND NORMAL BATTERY DEPLETION. IMPEDANCE READINGS WERE OVER 40,000 OHMS ON CONTACT 11. 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 75 YR Required Intervention LEAD: MODEL 3387S, LOT# V281277| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN001263V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN001268V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387S, LOT# V281277| IMPLANTED:| EXPLANTED: