BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2131654 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00913
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    March 17, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: "INADVERTENT MALPOSITION OF A PERMANENT PACEMAKER VENTRICULAR LEAD INTO THE LEFT VENTRICLE WHICH WAS INITIALLY MISSED AND DIAGNOSED TWO YEARS LATER: A CASE REPORT." J. MED. CASE REP. MARCH 17 2011;5.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS LEAD. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THE NEW-ONSET OF ATRIAL FIBRILLATION. THE PHYSICIAN IMPLANTED A DUAL CHAMBER PACEMAKER SYSTEM. ON THE FIRST POSTOPERATIVE DAY, ROUTINE INTERROGATION OF THE RIGHT VENTRICULAR (RV) LEAD SHOWED A LOSS OF CAPTURE. MACRODISPLACEMENT OF THE RV LEAD WAS SUSPECTED, AND SUBSEQUENTLY IT WAS REPOSITIONED. DURING THE FOLLOWING FOUR MONTHS, THE PATIENT DEVELOPED RECURRENT EPISODES OF ATRIAL FLUTTER, WHICH WERE SUCCESSFULLY ABLATED. THE PHYSICIAN NOTED THE PRESENCE OF A LARGE PATIENT FORAMEN (OPENING BETWEEN THE LEFT AND RIGHT ATRIA). TWO YEARS LATER DURING A ROUTINE FOLLOW UP VISIT, THE ECHOCARDIOGRAM SHOWED THE "VENTRICULAR PACING WIRE TO PASS FROM THE RIGHT ATRIUM TO THE LEFT ATRIUM AND THEN THROUGH THE MITRAL VALVE TO THE LEFT VENTRICLE WITH NO VISIBLE ATTACHED THROMBI."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 5092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R UNKNOWN IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5594 IMPLANTABLE PACING LEAD