BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3061764 · Received April 16, 2013

    Report

    Report Number
    2124215-2013-06258
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 12, 2013
    Report Date
    August 9, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE ICD IDENTIFIED AN ARC MARK ON THE DEVICE CASE. REVIEW OF DEVICE MEMORY FOUND A SHORTED LEAD FAULT WAS RECORDED. AN X-RAY OF THE DEVICE REVEALED THAT THE INTERNAL HIGH VOLTAGE FUSE WAS DAMAGED (I.E., NO LONGER INTACT). THE DAMAGE TO THE FUSE MOST LIKELY OCCURRED DURING DELIVERY OF A SHOCK THAT RESULTED IN THE SHORTED SHOCK LEAD FAULT. THE DAMAGE TO THE HIGH VOLTAGE FUSE PREVENTED ANY SUBSEQUENT CHARGING OF THE HIGH VOLTAGE CAPACITORS AND DELIVERY OF SHOCK THERAPY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE APPROXIMATELY ONE WEEK LATER. THE PACE/SENSE PORTION OF THE IMPLANTABLE DEFIBRILLATION LEAD WAS SURGICALLY ABANDONED AND THE HIGH VOLTAGE PORTION REMAINS IN SERVICE. ANOTHER PACE/SENSE LEAD WAS USED. THE RETURN OF THIS PRODUCT IS NOT EXPECTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED A LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT LESS THAN 20 OHMS. INTERROGATION OF THE DEVICE REVEALED A SHOCK INTO A SHORTED LEAD CONDITION AND LIMITED DEVICE FUNCTIONALITY FAULT MESSAGES. IT WAS REPORTED THAT THE DEVICE HAD DELIVERED SHOCK THERAPY AND APPROXIMATELY THREE HOURS LATER, THE PATIENT FELL DOWN AND SUSTAINED A HEAD INJURY. THE PATIENT WAS UNSURE IF THEY PASSED OUT OR TRIPPED. DURING THE INTERROGATION, THE PATIENT WAS IN ATRIAL FIBRILLATION (AF) WITH VENTRICULAR CONDUCTION AT AROUND 80 BEATS PER MINUTE (BPM). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED A SUSPECTED LEAD ISSUE AND THAT THE DEVICE WOULD NOT PROVIDE TACHYCARDIA THERAPY. TS RECOMMENDED DEVICE AND LEAD REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163442 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening 4017| 0158| T180| E110| 4453| 1283