BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2041689 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01038
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 1, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P010012
    Removal / Correction Number
    Z-0609-10 TO Z-0610-10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A WEAKENED HEADER BOND. THERE WERE NO OBSTRUCTIONS IN ANY OF THE BARRELS, ALL SEAL PLUGS WERE INTACT AND THE HEADER WAS NOTED TO BE SECURED TO THE DEVICE CASE. LEAD SEAL WITNESS MARKS WERE PRESENT, INDICATING THAT THE RV LEAD WAS FULLY INSERTED. THERE WERE TOOL MARKS AND DENTS IN THE FRONT OF THE DEVICE CASE AND BACK EDGE OF THE DEVICE. AN X-RAY WAS PERFORMED WHICH REVEALED THAT THE DF-, RV RING AND RV TIP HEADER WIRES WERE CRACKED. ANALYSIS OF THE DEVICE MEMORY CONFIRMED THAT OPEN SHOCK IMPEDANCES HAD BEEN RECORDED SINCE (B)(6) 2010. ANALYSIS NOTED THAT THE OPEN SHOCK IMPEDANCE MEASUREMENTS WERE DUE TO THE FRACTURED DF- HEADER WIRE. IT WAS ALSO FOUND THAT THE RV RING AND RV TIP HEADER WIRES BECAME CRACKED EITHER DURING OR AFTER THE EXPLANT PROCEDURE AS DAILY RV IMPEDANCES WERE STABLE THROUGHOUT THE IMPLANT TIME AND RV NOISE WAS NOT NOTED ON THE STORED ELECTROGRAMS RETAINED IN DEVICE MEMORY. IMPROVEMENTS HAVE BEEN MADE TO THE MANUFACTURING PROCESS IN ORDER TO STRENGTHEN THE BOND BETWEEN THE HEADER AND THE DEVICE CASE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT A REVISION PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, AFTER PULLING THE DEVICE OUT OF THE POCKET, WITH GENTLE PRESSURE APPLIED TO THE SIDE OF THE HEADER, IT WAS NOTED TO HAVE VISIBLY TILTED TO ONE SIDE. IT WAS ALLEGED THAT THIS DEVICE HEADER SEPARATED DUE TO THE MUSCULAR PRESSURES OF A SUB-PECTORAL IMPLANT. IT WAS FURTHER NOTED THAT THIS PATIENT HAS EMERY-DREIFUSS DISEASE, CAUSING A VERY MUSCULAR CHEST AREA. THE DEVICE WAS EXPLALNTED AND IT WAS NOTED THAT WHEN THE REPLACEMENT DEVICE WAS IMPLANTED WITH THE PATIENT'S CHRONIC DEFIBRILLATION LEAD, ALL LEAD MEASUREMENTS WERE NORMAL. THE EXPLANTED DEVICE WAS LATER RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LATITUDE SYSTEM DETECTED A RED ALERT FROM THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DUE TO HIGH SHOCK IMPEDANCES. NOISE ON THE RIGHT VENTRICULAR (RV) AND SHOCK CHANNELS WAS ALSO NOTED. TECHNICAL SERVICES (TS) DISCUSSED SEVERAL TROUBLESHOOTING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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
    1 262 MO Required Intervention E102| 0184