BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACEL BIPOLAR PACING CATH 6F RHC

    MDR report key: 3242890 · Received July 19, 2013

    Report

    Report Number
    2182269-2013-00062
    Event Type
    Injury
    Date Received
    July 19, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    K772197
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE SERIAL NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE PACEL BIPOLAR PACING CATHETER INSTRUCTIONS FOR USE (IFU) STATES THAT POTENTIAL ADVERSE EFFECTS MAY BE ASSOCIATED WITH THE PACEL BIPOLAR PACING CATHETER. THESE INCLUDE ARRHYTHMIAS, CARDIAC PERFORATION, CARDIAC TAMPONADE, AND DAMAGE TO VESSEL OR VALVE STRUCTURES.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM INDICATED A 6F PACEL BIPOLAR PACING CATHETER WAS SELECTED FOR USE. THE PATIENT DEVELOPED A TAMPONADE AND A PERICARDIOCENTESIS WAS PERFORMED, WITH NO FURTHER PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339130 PACEL BIPOLAR PACING CATH 6F RHC ELECTRODE, PACEMAKER, TEMPORARY DTB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R