BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACEL BIPOLAR PACING CATH 6F RHC

    MDR report key: 2914882 · Received January 9, 2013

    Report

    Report Number
    2182269-2013-00002
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 17, 2012
    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

    A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A 6F PACEL BIPOLAR PACING CATHETER WAS SELECTED FOR USE FOR TEMPORARY PACING WHILE THE PT WAS WAITING FOR A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE. A PERFORATED VENTRICLE WAS REPORTED IN CONJUNCTION WITH THE USE OF THE DEVICE, REQUIRING SURGICAL REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11714 PACEL BIPOLAR PACING CATH 6F RHC ELECTRODE, PACEMAKER, TEMPORARY DTB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R