BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1950983 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22739
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 22, 2010
    Report Date
    September 26, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P010012
    Removal / Correction Number
    Z-0609-10 TO Z-0610-10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT LOSS OF RV CAPTURE WAS ALSO QUESTIONED. A REVISION PROCEDURE WAS THEREFORE PERFORMED. DURING THE PROCEDURE, THE PHYSICIAN FOUND THAT THE CONNECTIONS WERE NOT TIGHT. THE LEAD WAS TESTED THROUGH THE PACING SYSTEM ANALYZER (PSA) AND CHECKED OUT FINE. THE LEAD WAS THEN RECONNECTED TO THE DEVICE AND RV LEAD IMPEDANCES OF 440 OHMS WERE NOTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT PACING IMPEDANCE MEASUREMENTS CONTINUED TO FLUCTUATE. NOISE WAS ALSO NOTED ON THE RV CHANNEL, FOR WHICH ANTI TACHYCARDIA PACING (ATP) WAS DELIVERED. IT WAS NOTED THAT THRESHOLDS AND SHOCK IMPEDANCES REMAINED STABLE. TS DISCUSSED TROUBLESHOOTING OPTIONS; HOWEVER, IT WAS NOTED THAT THE THIS WOULD BE DISCUSSED FURTHER AS IT WAS FELT THAT INTERVENTION WAS NEEDED AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED INCREASED RIGHT VENTRICULAR (RV) IMPEDANCES OF GREATER THAN 2,000 OHMS. SUBSEQUENT MEASUREMENTS DECREASED TO 1,778 OHMS. IT WAS NOTED THAT THE PHYSICIAN WAS AWARE OF THIS AND ELECTED TO CONTINUE TO MONITOR THE PATIENT CLOSELY. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    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 79 YR Hospitalization| R 0185| E102