BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3210134 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07418
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    March 21, 2013
    Report Date
    May 16, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. VISUAL INSPECTION NOTED NO ANOMALIES. X-RAY INSPECTION VERIFIED THAT THE DEVICE PLASMA FUSE WAS OPEN. EXAMINATION OF THE DEVICE MEMORY CONFIRMED THAT THE DEVICE HAD SHOCKED INTO A SHORTED LEAD CONDITION ON (B)(6) 2013 DURING EPISODE 2749. VERIFIED THAT THE DEVICE STILL HAD PROPER RV PACING OUTPUT. ANALYSIS ON THE RETURNED PORTION OF THE RV LEAD, WHICH WAS ONLY 11.5 CENTIMETERS (CM) LONG, COULD NOT CONFIRM THAT THE LEAD WAS SHORTED. THE DEVICE SUSTAINED INDUCED HIGH ENERGY OVERSTRESS DAMAGE RESULTING IN AN OPEN PLASMA FUSE AS A RESULT OF SHOCKING INTO A SHORTED LEAD CONDITION. THIS WAS CONFIRMED TO BE THE CAUSE OF THE REPORTED OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD RECEIVED A SHOCK. AFTER THE SHOCK, THE PATIENT REPORTED HEARING BEEPING TONES. THE PATIENT WAS SEEN FOR A DEVICE INTERROGATION WHERE A FAULT CODE WAS DISPLAYED THAT INDICATED THERE WAS A SHORT CIRCUIT CONDITION. SHOCK IMPEDANCE MEASUREMENTS WERE NOTED TO HAVE BEEN LESS THAN 20 OHMS. THE PATIENT WAS SEEN FOR A REVISION PROCEDURE WHERE THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310805 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| L| R E110| 1861| 4087| 4245| 0148