BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1950434 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22279
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    August 26, 2010
    Report Date
    November 12, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS CRT-D WAS THOROUGHLY INSPECTED AND ANALYZED. PIN GAUGE TESTING CONFIRMED THAT ALL PORT DIAMETERS WERE WITHIN DESIGN SPECIFICATION RANGE, HOWEVER, THE DIAMETER OF THE RIGHT VENTRICULAR SPRING CONTACT COMPONENT WAS FOUND TO BE OUT OF SPECIFICATION. THIS OUT OF SPECIFICATION SPRING CONTACT MAY HAVE CONTRIBUTED TO THE CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, INTERROGATION OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE REVEALED THE PATIENT WITH THIS DEVICE HAD RECEIVED AN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) SHOCK DUE TO OVERSENSING NOISE. WHEN THE PHYSICIAN MOVED THE ARM OF THE PATIENT THE NOISE WAS REPRODUCED. POCKET MANIPULATION DID NOT REVEAL OVERSENSING. THE PHYSICIAN DID NOT THINK THERE WAS A CONNECTION ISSUE. IT WAS THOUGHT THERE MAY BE A RIGHT VENTRICULAR LEAD ISSUE AS THE IMPEDANCE MEASUREMENTS WERE UNSTABLE. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED AND REVIEWED THE DATA. NOISE WAS OVERSENSED GREATER THAN TWO SECONDS, HOWEVER, THERE WAS NO PACING INHIBITION AS THE PATIENT HAS AN UNDERLYING INTRINSIC RHYTHM. APPROPRIATE RIGHT VENTRICULAR PACING WAS NOTED. IT WAS SUGGESTED TO FURTHER DETERMINE WHETHER THE LEAD IS DAMAGED, HOWEVER THERE IS NO EVIDENCE OF SHOCK IMPEDANCE PERFORMANCE. IT WAS NOT THOUGHT THE ISSUE WAS DUE TO A LEAD/DEVICE CONNECTION ISSUE. ADDITIONAL INFORMATION WAS RECEIVED: A FURTHER EPISODE OF OVERSENSING WAS REVEALED WITHOUT ADVERSE PATIENT EFFECTS. A REVISION PROCEDURE WAS PERFORMED; THIS DEVICE WAS DEACTIVATED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1