BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2153635 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06615
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 21, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION FOUND NO ARC MARKS ON THE CASING AND THERE WAS NO EVIDENCE OF A LOOSE CONNECTION. AN X-RAY OF THE DEVICE WAS COMPLETED AND NO IRREGULARITIES WERE IDENTIFIED. THE DEVICE CASE WAS OPENED IN ORDER FOR THE INTERNAL COMPONENTS TO BE ASSESSED. THE REASON FOR THE NO INTERROGATION WAS DUE TO DAMAGE FROM ELECTRICAL OVERSTRESS THAT DEPLETED THE BATTERY. DETAILED ANALYSIS CONCLUDED THAT AN INTERNAL SHORT WITHIN A TRANSFORMER RESULTED IN DAMAGE THROUGHOUT THE INTERNAL CIRCUITRY OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY CONFIRMED THAT THE DEVICE COULD NOT BE INTERROGATED AND A MEMORY DOWNLOAD COULD NOT BE PERFORMED. THE DEVICE IS CURRENTLY UNDERGOING DETAILED ANALYSIS TO DETERMINE ROOT CAUSE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS PATIENT WAS ADMITTED TO THE HOSPITAL AND THE DEVICE COULD NOT BE INTERROGATED. THE DEVICE HAD BEEN CHECKED ON THE PREVIOUS DAY AND NO ANOMALIES WERE IDENTIFIED. THE PATIENT REPORTED A "BURNING SENSATION" NEAR THE POCKET THAT STARTED WHEN HE WAS BENDING OVER REMOVING CLOTHES FROM A DRYER. THE DEVICE COULD NOT BE INTERROGATED DESPITE ATTEMPTS WITH MULTIPLE PROGRAMMERS. ADDITIONALLY, DEVICE TONES WERE NOT GENERATED DURING MAGNET APPLICATION. THE PATIENT COMMENTED THAT THE BURNING SENSATION RESOLVED WHEN THE MAGNET WAS APPLIED. TECHNICAL SERVICES WAS NOTIFIED THAT THE PATIENT WAS BEING TRANSFERRED TO ANOTHER HOSPITAL FOR AN IMMEDIATE DEVICE REPLACEMENT. TECHNICAL SERVICES DISCUSSED LEAD EVALUATION (SHORTED LEAD CONDITION) AT THE TIME OF THE DEVICE REPLACEMENT PROCEDURE. TECHNICAL SERVICES WAS INFORMED THAT THE PHYSICIAN PLANNED TO EXTRACT THE ENTIRE DEVICE/LEAD SYSTEM. ADDITIONALLY, UPON REMOVAL OF THE DEVICE, THE HOSPITAL PROCEDURE PROTOCOLS REQUIRE THAT THE DEVICE NEEDS TO BE CLEANED AND SENT THROUGH THE PATHOLOGY DEPARTMENT FOR DOCUMENTATION PURPOSES. THE LOCAL REPRESENTATIVE REPORTED THAT THE MODEL#0158 RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS SURGICALLY CUT AND CAPPED BELOW THE YOKE. THE MODEL#4136 RIGHT ATRIAL (RA) LEAD REMAINS IN-SERVICE. VISUAL INSPECTION OF THE DEVICE CASING DID NOT IDENTIFY ANY DAMAGE OR ARC MARKS. THE RA AND RV LEAD DIAGNOSTIC MEASUREMENTS AT THE START OF THE PROCEDURE WERE ALL WITHIN NORMAL RANGE. THE PATIENT HAD RECEIVED APPROPRIATE SHOCK THERAPY IN (B)(6) 2011. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.

    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 54 YR Hospitalization| L| R E110| 4136| 0158