BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1951475 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23058
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 24, 2010
    Report Date
    March 23, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0609-10 TO Z-0610-10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS IS CURRENTLY ON-GOING.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A WEAKENED HEADER BOND. AN X-RAY OF THE DEVICE HEADER FOUND THE RV TIP AND DF HEADER WIRES WERE FRACTURED. DETAILED ANALYSIS REVEALED THAT THE RV HEADER WIRE FRACTURED DUE TO FATIGUE. THE DF- HEADER WIRE WAS IN THE PROCESS OF FRACTURING, BUT MAINTAINED ELECTRICAL CONNECTION WHILE THE DEVICE WAS IMPLANTED. THIS WAS CONCLUDED BECAUSE ALL THE SHOCK IMPEDANCES WERE STABLE AND WITHIN THE NORMAL RANGE WHILE IMPLANTED. AN OPEN SHOCK IMPEDANCE WAS REPORTED DURING THE EXPLANT PROCEDURE. IT IS BELIEVED THE DF- HEADER WIRE BECAME COMPLETELY SEVERED AT THAT TIME. IMPROVEMENTS HAVE BEEN MADE TO THE MANUFACTURING PROCESS IN ORDER TO STRENGTHEN THE BOND BETWEEN THE HEADER AND THE DEVICE CASE. PIN GAUGE TESTING CONFIRMED THAT ALL PORT DIAMETERS WERE WITHIN DESIGN SPECIFICATION RANGE; HOWEVER, THE DIAMETER OF THE IS-1 RV SPRING CONTACT COMPONENT WAS FOUND TO BE OUT-OF-SPECIFICATION. THIS MAY HAVE RESULTED IN A SUBOPTIMAL CONNECTION WITH THE LEAD TERMINAL. THIS ISSUE MAY HAVE CONTRIBUTED TO THE CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT DURING A CHANGEOUT PROCEDURE EXTENSIVE TROUBLESHOOTING WAS PERFORMED AND IT WAS BELIEVED THAT THERE WAS AN ISSUE WITH THE HEADER PORT OF THIS PRODUCT. THIS PRODUCT WAS RETURNED FOR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION VIA A LATITUDE RED ALERT THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED HIGH, OUT OF RANGE PACING IMPEDANCES. THE LOCAL FIELD REPRESENTATIVE (FR) INDICATED THAT THE PATIENT WAS SCHEDULED FOR A FOLLOW UP APPOINTMENT WITH THE DEVICE FOLLOWING PHYSICIAN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION FROM THE FR INDICATED THAT THE DEVICE HAD BEEN IMPLANTED SUBMUSCULARLY.

    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 58 YR Required Intervention 0158| 4470| E110