BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3210990 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07602
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD REPRESENTATIVE REPORTED THAT THE PATIENT WAS BROUGHT TO THE EP LAB FOR A COMMANDED SHOCK. PRIOR TO THE PROCEDURE, THE SHOCK LEAD IMPEDANCE MEASUREMENTS WERE CHECKED IN ALL CONFIGURATIONS, AND ALL WERE WITHIN RANGE. THE PATIENT WAS SEDATED AND A 31 JOULE SHOCK WAS DELIVERED IN THE TRIAD CONFIGURATION. THE IMPEDANCE WAS 54 OHMS. ALL LEAD INTEGRITY TESTS PRODUCED MEASUREMENTS THAT WERE WITHIN NORMAL LIMITS FOLLOWING THE COMMANDED SHOCK. NO FURTHER INTERVENTION OR EVALUATION WAS PLANNED AT THIS TIME. THE DEVICE AND LEAD REMAIN IN SERVICE AND WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP, THIS RIGHT VENTRICULAR (RV) LEAD AND ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. ALL SHOCK CONFIGURATIONS WERE CHECKED; TRIAD SHOWED AN OUT-OF-RANGE MEASUREMENT, WHILE THE OTHER CONFIGURATIONS WERE 111 AND 112 OHMS. AN X-RAY WAS PERFORMED BUT WAS INCONCLUSIVE OF ANY LEAD PROBLEMS. THE PATIENT WAS ADMITTED TO THE HOSPITAL TO DELIVER A SHOCK TO TEST THE LEAD INTEGRITY. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED TROUBLE SHOOTING TO CHECK LEAD CONNECTIONS, IF THE PHYSICIAN ELECTED TO OPEN THE POCKET. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309890 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E163

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R 0185| E163| 4087