BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2173125 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10305
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 23, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    MICROSCOPIC VISUAL INSPECTION OF THE HEADER WAS UNDERTAKEN AND IMPRESSIONS FROM THE LEAD SEAL RINGS IN THE LEAD BARRELS INDICATE THAT THE RV LEAD HAD NOT BEEN FULLY INSERTED INTO THE DEVICE HEADER. AN XRAY VERIFIED THAT ALL FEEDTHRU WIRES WERE INTACT. A PIN GAUGE TEST WAS PERFORMED ON THE RV, DF(+) AND DF(-) PORTS AND NO ANOMALIES WERE IDENTIFIED. THE DEVICE WAS PUT THROUGH A SERIES OF AUTOMATED TESTS, WHICH VERIFIED THE PERFORMANCE OF DEFIBRILLATION, PACING, SENSING, AND RECORDING FUNCTIONS OF THE DEVICE. IN CONCLUSION, IT APPEARS THAT THE CAUSE OF THE CLINICAL OBSERVATION WAS ATTRIBUTED TO UNDER-INSERTION OF THE RV LEAD AT THE TIME OF THE PROCEDURE. THE DEVICE PERFORMED NORMALLY THROUGHOUT LABORATORY TESTING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED A REVISION PROCEDURE TOOK PLACE AND THE DEVICE WAS EXPLANTED. PACING IMPEDANCES ON THE DATE OF EXPLANT WERE 1,500 OHMS WITH NO NOISE PRESENT. IT WAS REPORTED AS THE PHYSICIAN REACHED INTO THE POCKET THE IMPEDANCE DECREASED TO 670 OHMS. IT WAS VERIFIED BOTH VISUALLY AND ON FLUOROSCOPY THAT THE LEAD WAS NOT UNDERINSERTED INTO THE DEVICE HEADER. THE PHYSICIAN INSPECTED THE LEADS AND DEVICE HEADER AND NOTED NO ANOMALIES. THE LEAD WAS TESTED THROUGH THE PACING SYSTEM ANALYZER (PSA) AND REPORTED NORMAL MEASUREMENTS, INCLUDING MANIPULATION. THE LEAD REMAINS IN SERVICE WITH THE NEW DEVICE. ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXHIBITING A SPIKE IN PACING IMPEDANCE MEASUREMENTS FROM 900 TO 1,600 OHMS. THERE WAS NO NOISE NOTED ON ANY EPISODES AND NOISE WAS UNABLE TO BE RECREATED WITH ISOMETRICS AND POCKET MANIPULATIONS. ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT GOT INTO A NEAR MOTOR VEHICLE ACCIDENT LAST FALL WHICH REQUIRED THEM TO GO INTO DITCH TO AVOID HITTING THE CAR IN FRONT OF THEM. THE PATIENT WAS BLACK AND BLUE FROM THE SEATBELT AND THE DEVICE WAS UNDERNEATH THE SEATBELT. THE SPIKE IN THE PACING LEAD IMPEDANCES OCCURRED SHORTLY AFTER. ADDITIONALLY, THIS DEVICE IS IMPLANTED SUB-PECTORALLY AND THE PATIENT IS VERY ACTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR E102| T135| 0158