BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 2022128 · Received February 28, 2011

    Report

    Report Number
    3004209178-2011-01488
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO THE PT EXPERIENCED A LOSS THERAPY. IMMEDIATELY AFTER THE MESSAGE ELECTIVE REPLACEMENT INDICATOR SHOWED ON THE PT PROGRAMMER. MANUFACTURER'S REP DOES NOT BELIEVE THE BATTERY IS TOWARD END OF LIFE. AFTER THE ERI MESSAGE, A POWER ON RESET MODE WAS NOTED AND PT WAS ABLE TO CLEAR THIS AND REGAIN STIMULATION. THE PT HAS AN APPOINTMENT PENDING TO SEE THE HCP FOR REPROGRAMMING. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    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 LEAD: MODEL 3389S-40, LOT# V455934| EXPLANTED:| STIM ACCESSORY: MODEL 3555, LOT# N253295| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN008179V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V455934| EXPLANTED:| PROGRAMMER: MODEL 37642, LOT# UNKNOWN| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN008180V