BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2040078 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-00245
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    January 4, 2011
    Report Date
    August 1, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL INFORMATION THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DATA DISK SHOWED VARYING SHOCKING IMPEDANCES OUT OF RANGE WHILE PACING IMPEDANCES ON THE RIGHT VENTRICULAR LEAD REMAINED STABLE. TECHNICAL SERVICES DISCUSSED THAT POSSIBLE CAUSES FOR UNSTABLE AND HIGH SHOCK LEAD IMPEDANCES MAY BE POOR LEAD CONNECTION, LEAD ISSUE, OR A DEVICE COMPONENT FAILURE. DISCUSSED PERFORMING A HIGH RESOLUTION X-RAY TO EVALUATE PROPER SETSCREW POSITON AND CONNECTOR INSERTION. AT THIS TIME THE SYSTEM REMAINS IMPLANTED, SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY DURING A FOLLOW UP AN X-RAY REVEALED FRACTURE ON THE COMPETITOR LEAD. PROGRAMMING THE LEAD OFF STILL REVEALED OUT OF RANGE SHOCKING IMPEDANCES, THUS THE PHYSICIAN REPLACED THIS LEAD WITH A NEW BOSTON SCIENTIFIC RIGHT VENTRICULAR LEAD. THE NEW LEAD WAS CONNECTED TO THE DEVICE AND NORMAL SHOCKING IMPEDANCES WERE NOTED. THIS DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED FOLLOWING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT POST DEVICE CHANGE UNSTABLE SHOCK IMPEDANCES WERE NOTED. AT THE LATEST FOLLOW UP OUT OF RANGE SHOCKING IMPEDANCES WERE SEEN. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REPROGRAMMED BUT SHOCKING IMPEDANCES WERE STILL UNSTABLE. THE RIGHT VENTRICULAR LEAD IMPLANTED IS A COMPETITOR LEAD. A SAVE TO DISK WAS FORWARDED FOR ANALYSIS TO TECHNICAL SERVICES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R