BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2040718 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00856
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    December 7, 2009
    Report Date
    January 10, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD HAD AN INCREASE IN PACING IMPEDANCES AND A RISE IN PACING THRESHOLD MEASUREMENTS. THIS WOULD ONLY OCCUR DURING POCKET MANIPULATION AND WHEN THE PATIENT SAT IN CERTAIN POSITIONS. APPROXIMATELY ONE YEAR LATER, THE PACING IMPEDANCE MEASUREMENTS INCREASED TO GREATER THAN 2,000 OHMS. THERE WAS ALSO NOISE OBSERVED ON THE RV RATE/SENSE CHANNEL AND SHOCK ELECTROGRAM WITH POCKET MANIPULATION. THIS DID NOT RESULT IN ANY PACING INHIBITION AND THE PATIENT WAS NOT PACEMAKER DEPENDENT. A REVISION PROCEDURE TOOK PLACE AND THE RV LEAD WAS TESTED THROUGH THE PACING SYSTEM ANALYZER (PSA). ALL LEAD MEASUREMENTS WERE WITHIN NORMAL RANGE. THE LEAD WAS RECONNECTED TOT HE DEVICE AND MEASUREMENTS RETURNED TO NORMAL RANGE. THERE WAS SUSPICION OF A SET SCREW ISSUE. THE DEVICE AND LEAD REMAIN IN SERVICE WITHOUT FURTHER COMPLICATION. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention 0157| E110| 4469