BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 1850924 · Received September 29, 2010

    Report

    Report Number
    3004209178-2010-07428
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 31, 2010
    Manufacturer
    MEDTRONIC 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): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED INTERROGATION OF THIS IMPLANTABLE NEUROSTIMULATOR (INS) SHOWED 509 ERROR CODE, 0 VOLTS AND BATTERY "OK". THE 509 ERROR CODE INDICATED "POOR COMMUNICATION" MESSAGE. IMPEDANCE MEASUREMENT WAS NOT POSSIBLE. THERE WAS NO INJURY TO PATIENT AND DEVICE WAS REPLACED. THE PATIENT WAS "OK". ADDITIONAL INFORMATION WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN000556N| EXPLANTED:| EXPLANTED:| UNK: MODEL UNK, LOT# UNK| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN000978N