BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3040754 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02396
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    November 29, 2012
    Report Date
    February 26, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY IT WAS DETERMINED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PASSED ALL TESTS. ALLEGATIONS OF NONCONVERSION, INAPPROPRIATE SHOCK, AND HIGH SHOCK IMPEDANCE WERE NOT CONFIRMED. FAULT/ERROR CODES WERE CONFIRMED. HOWEVER, OPEN LEAD FAULTS WERE NOT DUE TO THE ICD. ANALYSIS VERIFIED NORMAL DEVICE FUNCTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT LAST AUTUMN, THE PATIENT PRESENT TO EMERGENCY ROOM. THEY HAD RECEIVED 4 SHOCKS DELIVERED WITHIN SIX MINUTES. IT WAS INDICATED AT THAT TIME THAT THE DEVICE NEEDED TO BE EVALUATED BY A PHYSICIAN. ADDITIONAL INFORMATION WAS LATER RECEIVED, THAT PRIOR TO THESE SHOCKS, HIGH SHOCK IMPEDANCES WERE NOTED. IMPEDANCE WAS AT 184 OHMS PRIOR TO THE SHOCKS, BUT RETURNED TO NORMAL AFTER THE PATIENT RECEIVED THIS SHOCKS. DURING WINTER, THE PATIENT WAS AGAIN SEEM IN THE EMERGENCY ROOM. THIS TIME, HE HAD EXPERIENCED REAL VENTRICULAR FIBRILLATION, AND RECEIVED A TOTAL OF EIGHT SHOCKS. HE WAS CONVERTED ON THE EIGHT. AN INTERROGATION SHOWED THAT THERE WAS AN ERROR CODE FOR THE FIRST SEVEN SHOCKS. THE PATIENT WAS CONVERTED ON THE EIGHT REVERSE POLARITY (WOULD HAVE BEEN INITIAL) WITH A HIGH 90'S IMPEDANCE. THE PATIENT HAD TWO OR THREE ADDITIONAL EPISODES WHILE IN THE ER, WHICH WERE CONVERTED WITH THE FIRST 31J SHOCK. NORMAL IMPEDANCES WERE NOTED AT THIS POINT. IT WAS NOTED THAT THE PATIENT HAD A LOT OF UNDERLYING ISSUES, LIKE BLEEDING, AND WAS IN THE HOSPITAL FOR A COUPLE OF WEEKS. A FAULT CODE WAS DISCUSSED. THE REASON FOR THE NON-CONVERSION WAS NOT ENTIRELY CLEAR. IT WAS INDICATED THAT NO FRACTURE WAS VISIBLE ON THE LEAD. THE LEAD WAS CAPPED DURING A WINTER REVISION PROCEDURE. THERE WERE 7.5 YEARS OF LONGEVITY LEFT, AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS OPERATING NORMALLY. HOWEVER, THE PHYSICIAN OPTED TO REPLACE THE ICD. THE LEAD WAS CAPPED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144064 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R 4054| 0184| T125| E110