BEUDAMED
    FDA Adverse Event Injury Summary report: N

    273718

    MDR report key: 273718 · Received October 29, 1999

    Report

    Report Number
    273718
    Event Type
    Injury
    Date Received
    October 29, 1999
    Date of Event
    September 14, 1999
    Report Date
    September 27, 1999
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED WITH COMPLAINT OF LEFT SCAPULAR PAIN AND GENERALIZED WEAKNESS FOR ABOUT 1 WEEK. AT 4 A.M. THE PAIN WORSENED AND RADIATED TO THEIR JAW WITH NAUSEA & VOMITING. THE PAIN WAS NOT RELIEVED BY NIG BUT AFTER ARRIVING AT ER THE PT WAS FEELING BETTER. THEIR VITAL SIGNS WERE STABLE. THE PT HAS REQUIRED PLACEMENT OF A BIPOLAR PACEMAKER IN 1997 FOR SYMPTOMATIC BRADYCARDIA. ON THE DAY OF ADMISSION PT BEGAN TO FEEL THEIR PACEMAKER CONTINUOUSLY PACING ALONG WITH THE NAUSEA & VOMITING AND CHEST PAIN. ATTEMPTS TO INTERROGATE THE PACEMAKER REVEALED ASYNCHRONOUS PACING WITH A RATE OF 70. ATTEMPTS TO REPROGRAM THE PACEMAKER W/WAND WERE NOT SUCCESSFUL. CONTACT WAS MADE WITH THE MFR REP AND DETERMINED THE PACEMAKER TO BE IN BACK-UP MODE. THE GENERATOR WAS REMOVED AND REPLACED WITH A DUAL CHAMBER TEMPO DR PACEMAKER.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R