BEUDAMED
    FDA Adverse Event Other Summary report: N

    ST JUDE MEDICAL, ICD DEVICE

    MDR report key: 1738155 · Received June 22, 2010

    Report

    Report Number
    MW5016503
    Event Type
    Other
    Date Received
    June 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INDICATIONS: INDICATION FOR THE PROCEDURE IS DECOMPENSATED CONGESTIVE HEART FAILURE, WITH A HISTORY OF IMPLANTABLE CARDIAC DEFIBRILLATOR BY ST JUDE MEDICAL. THE PT HAS AN EJECTION FRACTION APPROXIMATELY 25% TO 30%. THE PT HAS BEEN WORSENING WITH HIS CONGESTIVE HEART FAILURE WITH WORSENING LEG EDEMA AS WELL AS SHORTNESS OF BREATH WITH EXERTION AS WELL AS SHORTNESS OF BREATH AT REST AT TIMES. IN ADDITION TO THIS, THE PT HAS BEEN TAKING DOUBLE DOSE OF LASIX AT TIMES WHILE AT HOME. THE PT HAS A WIDE ORS, SECONDARY TO UNDERLYING PACING RHYTHM. IN ADDITION TO THIS, THE PT IS PACING IN THE VENTRICLE FOR GREATER THAN 70% OF THE TIME. THEREFORE, THE PT NOW PRESENTS FOR A BIVENTRICULAR PACEMAKER PLUS A CARDIAC DEFIBRILLATOR UPGRADE FROM AN IMPLANTABLE CARDIAC DEFIBRILLATOR. THE PT IS IN SINUS RHYTHM. THE LEAD LOCATIONS PRIOR TO THE PROCEDURE WHICH WERE EXAMINED ARE AS FOLLOWING: THE RIGHT VENTRICULAR LEAD WAS PLACED AT THE APEX. THE RIGHT ATRIAL LEAD WAS AT THE RIGHT ATRIAL APPENDAGE INTO THE POCKET. POCKET WAS SUTURED USING 2-0 VICRYL AND 4-0 VICRYL. NO COMPLICATIONS OCCURRED. THE PT LEFT THE RECOVERY ROOM IN A VERY STABLE CONDITION WITH BLOOD PRESSURE 127/68, HEART RATE OF 70 BEATS PER MINUTE. THE NEW IMPLANTABLE BIVENTRICULAR PACEMAKER PLUS CARDIAC DEFIBRILLATOR IS A ST JUDE MEDICAL 32007-36, (B)(4). A NEW LEFT VENTRICULAR LEAD TO THE CORONARY SINUS WAS 1156T-86 CM ST JUDE MEDICAL LEAD (B)(4). THE CHRONIC RIGHT VENTRICULAR LEAD IS A ST JUDE MEDICAL, 70001-65 CM (B)(4). THIS WAS IMPLANTED (B)(6) 2006. CHRONIC RIGHT ATRIAL LEAD IS A ST JUDE MEDICAL, MODEL #1688TC-52 CM (B)(4), AGAIN IMPLANTED (B)(6) 2006. EXPLANTED GENERATOR WAS AN IMPLANTABLE CARDIAC DEFIBRILLATOR V243, (B)(4) ST JUDE MEDICAL, IMPLANT DATE WAS (B)(6) 2006. EXPLANT DATE IS (B)(6) 2010. RIGHT ATRIAL T-WAVES WERE 1 MV, IMPEDANCE 560 OHMS, THRESHOLD OF 0.5 V AT 0.5 MSEC. RIGHT VENTRICULAR R-WAVES ARE 12 MV, IMPEDANCE OF 410 OHMS, THRESHOLD IS 0.75 V AT 0.5 MSECS. LEFT VENTRICLE R-WAVES ARE 10.7 MV, IMPEDANCE OF 1360 OHMS, THRESHOLD OF 1.4 V AT 0.5 MSECS. PACING MODALITY WAS SET AT 70 BEATS PER MINUTE, TURNED ON. NO COMPLICATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL, ICD DEVICE EXPLANTED GENERATOR AS AN IMPLANTABLE CARDIAC DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC. V243
    2 ST JUDE MEDICAL CHRONIC RIGHT VENTRICULAR LEAD LWS ST. JUDE MEDICAL, INC. 70001-65 CM
    3 ST JUDE MEDICAL CHRONIC RIGHT ATRIAL LEAD LWS ST. JUDE MEDICAL, INC. 1688TC-52 CM

    Patients

    Seq Age Sex Outcome Treatment
    1