BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

    MDR report key: 17536184 · Received August 12, 2023

    Report

    Report Number
    MW5143074
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    July 15, 2012
    Report Date
    August 10, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NIK
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    MEDICAL RECORDS RECEIVED A REPORT ON 7/20/12. IT WAS REPORTED ON (B)(6)2012, PATIENT WITH THIS LV LEAD CAME TO THE HOSPITAL AFTER EXPERIENCING ACUTE PECTORAL MUSCLE STIMULATION ON THE LEFT SIDE OF HER CHEST. THE DEVICE WAS INTERROGATED AT WHICH POINT THE MUSCLE STIMULATION THRESHOLD WAS 2 0V @ 1. OMS AND THE ATRIAL CAPTURE THRESHOLD WAS 2.7V @1.0MS. SINCE THE ATRIAL CAPTURE THRESHOLD WAS GREATER THAN THE MUSCLE STIMULATION THRESHOLD, THE PHYSICIAN ELECTED TO PROGRAM THE DEVICE TO VVT FOR THE TIME BEING. HOWEVER, AN X-RAY WAS PERFORMED WHICH SHOWED THIS LEAD TO HAVE BEEN DISLODGED FROM ITS IMPLANT POSITION. THE LEAD HAPPENED TO STILL HAVE GOOD THRESHOLDS, IMPEDANCE, AND SENSING VALUES. THE PATIENT WAS REFERRED TO HER IMPLANTING PHYSICIAN FOR LEAD REVISION. LEAD WAS IMPLANTED (B)(6)2012. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785026 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK ST. JUDE MEDICAL 1458Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown