BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 1926131 · Received November 10, 2010

    Report

    Report Number
    3004209178-2010-09185
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 21, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (DIAPHRAGMATIC).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED DIZZINESS AND NAUSEA. AFTER BEING PROGRAMMED FOR APPROX 1.2 HOURS AND TAKING MEDICATION, THE PT BECAME PALE AND DIAPHRAGMATIC. THE PT TURNED OFF THE STIMULATION BUT HAD NO CHANGE OF SYMPTOMS, SO THE STIMULATION WAS TURNED BACK ON. THE HEALTH CARE PROFESSIONAL REDUCED THE AMPLITUDE FROM 1.2V AND 1.1V TO 1.0V AND THE SYMPTOMS SUBSIDED. IT WAS NOTED THAT THE PT HAD NOT EATEN PRIOR TO THE REPROGRAMMING SESSION. ALL IMPEDANCES WERE WITHIN NORMAL RANGES. IT ALSO WAS REPORTED THAT THE PROGRAMMER HAD TWO OUT OF REGULATION (OOR) CONDITIONS. AFTER INTERROGATION, THE MESSAGE APPEARED TO REDUCE AMPLITUDE VALUES. THE PT HAD BEEN ON AN UPRIGHT POSITION DURING BOTH OOR INCIDENTS. DURING THE SECOND OOR EVENT, THE PT REPORTED NO UNPLEASANT SIDE EFFECTS AND GOOD SYMPTOM SUPPRESSION. DURING TROUBLESHOOTING, VOLTAGES WERE INCREASED 0.6V WITH NO OOR MESSAGE. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 PROGRAMMER: MODEL 37642, LOT# UNKNOWN| IMPLANTED:| EXPLANTED: