BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2173732 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11916
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 19, 2011
    Report Date
    December 13, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MOST RECENTLY, INFORMATION WAS RECEIVED THAT THERE IS STILL OUT-OF-RANGE PACE AND SHOCK IMPEDANCES WITH THE NON-BSC RV LEAD. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT RECOMMENDED BRINGING THE PATIENT FOR TROUBLESHOOTING, INCLUDING LOOKING FOR THE PRESENCE OF NOISE. THE CONSULTANT DID NOT SUGGEST TESTING AT 1.1 JOULES AND 41 JOULES COMMANDED SHOCKS GIVEN THE HISTORY OF THIS LEAD. THE LEAD AND THIS DEVICE REMAIN ACTIVELY IN SERVICE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE BOSTON SCIENTIFIC LOCAL AREA SALES REPRESENTATIVE STATED THAT A LEAD REVISION WAS PENDING. HOWEVER, MORE THAN A MONTH HAS PASSED AND A REVISION HAS NOT YET OCCURRED, PER AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN ASSOCIATION WITH THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR LEAD DID EXHIBIT OUT-OF-RANGE PACE IMPEDANCE. THE SOURCE OF THE ISSUE WAS NOT KNOWN FOR CERTAIN. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

    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 59 YR E102| V-196| 1580