BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3210018 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06240
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 15, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A WEAKENED HEADER BOND. X-RAY EXAMINATION WAS PERFORMED. THE HEADER WIRES HEADER WIRES FOUND TO BROKEN AS A RESULT OF THE HEADER SEPARATION AND MOVEMENT. THIS RESULTED IN THE CUSTOMER OBSERVATION AND COMPLAINTS IN THE FIELD. IMPROVEMENTS HAVE BEEN MADE TO THE MANUFACTURING PROCESS IN ORDER TO STRENGTHEN THE BOND BETWEEN THE HEADER AND THE DEVICE CASE. DEVICE NEVER TRIGGERED REPLACEMENT INDICATOR WHILE IMPLANTED. THIS DEVICE WAS ARCHIVED.

    Additional Manufacturer Narrative · 1

    TO DATE, THE EXTENDER AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAVE NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT THE PRODUCTS WILL UNDER GO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP VISIT, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) AND ENDOTAK LEAD EXTENDER REVEALED A RISE IN PACING IMPEDANCES GREATER THAN 2,000 OHMS. IN ADDITION, THE ARYTHMIA LOG BOOK WAS REVIEWED AND REVEALED HIGH PACING THRESHOLDS AND NOISE. THE PHYSICIAN ELECTED TO PERFORM A REVISION PROCEDURE. DURING THE REVISION THE PHYSICIAN NOTED TOUGH TISSUE HAD GROWN AROUND THE LEAD EXTENDER AND THE ICD. THE DECISION WAS MADE TO DAMAGE THE EXTENDER IN ORDER TO REMOVE THE DEVICE FROM THE SUBCOSTAL POCKET. UPON FURTHER VISUAL INSPECTION OF THE DEVICE HEADER THE PHYSICIAN FOUND THAT THE DEVICE HEADER HAD SEPARATED FROM THE CAN OF THE DEVICE. THE HEADER WAS THEN UNSCREWED FROM THE DEVICE AND THE LEAD WAS REMOVED AND TESTED WITH A PACING SYSTEM ANALYZER (PSA); WHICH REVEALED THAT THE LEAD HAD NORMAL AND IN RANGE VALUES. A NEW DEVICE WAS IMPLANTED AND CONNECTED TO THE EXISTING RV LEAD. THE NEW DEVICE AND LEAD WERE TESTED AND AGAIN REVEALED NORMAL IN RANGE MEASUREMENTS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICE AND ENDOTAK LEAD EXTENDER WILL BE SENT BACK FOR ANALYSIS WHILE THE RV LEAD REMAINS IN SERVICE. 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
    309163 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R