BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK C

    MDR report key: 1862112 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15684
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN AS TO WHETHER A SAVE TO DISK WAS INDEED PERFORMED. THE DEVICE WAS EXPLANTED AND THROWN OUT BY THE HOSPITAL AND THERE WAS WARRANTY QUESTIONS. THE LEADS WERE SURGICALLY ABANDONED. ALSO REPORTED WAS THAT THIS DEVICE HAD DELIVERED AN APPROPRIATE SHOCK BUT HAD SHORTED OUT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AN OUT-OF-RANGE SHOCK IMPEDANCE ON THESE DEFIBRILLATION LEADS. UPON FURTHER INVESTIGATION, THERE WAS INQUIRY AS TO THE DATE OF THE DETECTED. ONE EPISODE, THREE DAYS PRIOR TO THE DETECTION, NOTED A 31 JOULE SHOCK WITH AN IMPEDANCE OF 58 OHMS. IT WAS THEN NOTED THAT FIVE DAYS PRIOR TO THE DETECTION THERE WAS AN EPISODE IN WHICH A SHOCK WAS DELIVERED AND CONVERTED THE PATIENT BUT THAT IMPEDANCE WAS < 20 OHMS. TECHNICAL SERVICES ADVISED FURTHER EVALUATING THE PATIENT. A SAVE TO DISK AND MEMORY DUMP WAS ALSO TO BE PERFORMED AND SENT FOR FURTHER ANALYSIS. IT WAS UNKNOWN AS TO THE REASON OF THE DISCREPANCY IN DETECTION DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK C IMPLANTABLE LEAD NVY HISTORICAL CPI ST. PAUL 0064

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 4068| 1746| 0064| 6836| 1857| 1600| 0063| 6017