BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3211158 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08834
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 22, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. VISUAL INSPECTION NOTED SCRATCHES AND EVIDENCE OF ARCHING ON THE DEVICE CASE. THERE WAS MINOR BODY FLUID CONTAMINATION IN THE LEAD BARRELS. ALL SEAL PLUGS WERE INTACT AND ALL SET SCREWS OPERATED NORMALLY. AN X-RAY WAS PERFORMED WHICH REVEALED THAT THE PLASMA FUSE WAS BLOWN. THE CLINICAL OBSERVATIONS WERE ABLE TO BE CONFIRMED. OF NOTE, ANALYSIS OF THE RIGHT VENTRICULAR (RV) LEAD THAT HAD BEEN IMPLANTED WITH THE DEVICE REVEALED DAMAGE TO THE INSULATION DUE TO LEAD-ON-CAN CONTACT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDERGOING ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WAS SEEN FOR A DEVICE INTERROGATION. THE PATIENT'S PHYSICIAN REPORTED TO THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE (FR) THAT, UPON INTERROGATION, THE DEVICE DISPLAYED THREE FAULT CODES INDICATING A SHORTED CAPACITOR CONDITION. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A DEVICE CHANGE-OUT PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT DEVICE/LEAD CONNECTION APPEARED INTACT. SLIGHT DIVETS WERE SEEN ON THE FRONT AND THE BACK OF THE CAN. OF NOTE, FORCEPS WERE NOT USED TO REMOVE THE DEVICE FROM THE POCKET. A NEW DEVICE WAS IMPLANTED WITH THE CHRONIC RV LEAD AND ALL LEAD DIAGNOSTICS WERE WITHIN RANGE. A 41 JOULE SHOCK WAS THEN DELIVERED. A POPPING SOUND WAS HEARD AND THE DEVICE THEN DISPLAYED A FAULT CODE FOR A SHORTED CONDITION. THE CAN WAS REMOVED FROM THE POCKET AND DIVETS WERE SEEN THAT WERE SIMILAR TO WHAT WAS SEEN ON THE PREVIOUSLY EXPLANTED CAN. THE RV LEAD WAS EXPLANTED AND A NEW RV LEAD AND DEVICE WERE IMPLANTED WITHOUT FURTHER COMPLICATION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. ALL PRODUCTS HAVE BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309567 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R E163| 4054| 0184| E162| E110| 0295