BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPY ABLATION CATHETER 7F, 1304-7-25-M

    MDR report key: 3192897 · Received June 25, 2013

    Report

    Report Number
    2030404-2013-00048
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-IRVINE)
    Product Code
    OAD
    PMA / PMN Number
    P040042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETED IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    DURING A NON-SJM PACEMAKER IMPLANT AND AV NODE ABLATION PROCEDURE USING A THERAPY CATHETER, THE CATHETER, THE CATHETER WAS REPORTED TO HAVE DISLODGED THE NEWLY IMPLANTED PACING LEAD. THE PHYSICIAN COMPLETED THE NON-SJM PACEMAKER IMPLANT AND LEAD PLACEMENT WITH SUBSEQUENT POCKET CLOSURE. THE THERAPY ABLATION CATHETER WAS INSERTED AND, AS THE PHYSICIAN WAS MANEUVERING THE CATHETER ALONG THE RIGHT ATRIAL SEPTUM FOR AN AV NODE ABLATION, THE RIGHT VENTRICULAR PACEMAKER LEAD PREVIOUSLY PLACED WAS DISLODGED. THE HIS REGION WAS ABLATED UNSUCCESSFULLY SO THE PHYSICIAN REPLACED THE THERAPY ABLATION CATHETER WITH A NON-SJM ABLATION CATHETER. THE AV NODE WAS ABLATED SUCCESSFULLY AND THE PACEMAKER POCKET WAS REOPENED TO REPOSITION THE DISLODGED PACEMAKER LEAD. THE PATIENT WAS ASYMPTOMATIC THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289492 THERAPY ABLATION CATHETER 7F, 1304-7-25-M CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC. (AF-IRVINE) 83405 3840769

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NON-SJM PACEMAKER| BIOSENSE WEBSTER ABLATION CATHETER