BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3904329 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10222
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 10, 2014
    Report Date
    May 10, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED TOOL MARKS ON THE HEAD AND CONFIRMED THE CLINICAL OBSERVATION OF A WEAKENED HEADER BOND. X-RAY EXAMINATION WAS PERFORMED. THE RIGHT VENTRICULAR FEEDTHROUGH WIRES WERE FOUND TO BE FRACTURED. IMPROVEMENTS HAVE BEEN MADE TO THE MANUFACTURING PROCESS IN ORDER TO STRENGTHEN THE BOND BETWEEN THE HEADER AND THE DEVICE CASE. LABORATORY ANALYSIS CONFIRMED THE WEAKENED HEADER BOND TO CONTRIBUTE TO THE NOTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED INAPPROPRIATE SHOCKS DUE TO NOISE AND OVERSENSING. THE PATIENT WAS REFERRED FOR A REVISION PROCEDURE DUE TO UNSPECIFIED DAMAGE TO THEIR CHRONIC RV LEAD AND DISCOMFORT DUE TO THE LOCATION OF THE ICD. DURING THE REVISION, THE CHRONIC RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE ICD WAS MOVED FROM A SUBCOSTAL TO SUBPECTORAL POSITION. MEASUREMENTS OBTAINED ON THE PACING SYSTEM ANALYZER (PSA) SHOWED GOOD VALUES FOR THE NEWLY IMPLANTED LEAD. DURING THE PROCESS OF CLOSING THE DEVICE POCKET, HIGH RV PACE IMPEDANCES GREATER THAN 2,000 OHMS WERE OBSERVED IN ADDITION TO HIGH PACING THRESHOLDS AND DIMINISHED SENSING. AT THIS TIME IT WAS DISCOVERED THAT THE ICD HEADER WAS LOOSE AND THE DEVICE WAS EXPLANTED AND REPLACED WITH A NEW ICD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED INAPPROPRIATE SHOCKS DUE TO NOISE AND OVERSENSING. THE PATIENT WAS REFERRED FOR A REVISION PROCEDURE DUE TO UNSPECIFIED DAMAGE TO THEIR CHRONIC RV LEAD AND DISCOMFORT DUE TO THE LOCATION OF THE ICD. DURING THE REVISION, THE CHRONIC RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE ICD WAS MOVED FROM A SUBCOSTAL TO SUBPECTORAL POSITION. MEASUREMENTS OBTAINED ON THE PACING SYSTEM ANALYZER (PSA) SHOWED GOOD VALUES FOR THE NEWLY IMPLANTED LEAD. DURING THE PROCESS OF CLOSING THE DEVICE POCKET, HIGH RV PACE IMPEDANCES GREATER THAN 2,000 OHMS WERE OBSERVED IN ADDITION TO HIGH PACING THRESHOLDS AND DIMINISHED SENSING. AT THIS TIME IT WAS DISCOVERED THAT THE ICD HEADER WAS LOOSE AND THE DEVICE WAS EXPLANTED AND REPLACED WITH A NEW ICD. THIS ICD IS PART OF THE SUBPECTORAL IMPLANT 2009 PRODUCT ADVISORY, WHICH WAS INITIALLY COMMUNICATED ON (B)(4) 2009. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND CHRONIC LEAD ARE NO LONGER IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385109 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 F102| F161