BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 4884358 · Received July 1, 2015

    Report

    Report Number
    2124215-2015-07103
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    May 20, 2015
    Report Date
    June 5, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE ICD IDENTIFIED NO ANOMALIES. REVIEW OF DEVICE MEMORY FOUND A SHORTED LEAD FAULT (FAULT CODE 1005) 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 THE 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD COMPLAINED OF CHEST PAIN. UPON INTERROGATION OF THE ICD WITH A PROGRAMMER, A SHOCK LEAD SHORTED MESSAGE WAS OBSERVED. REVIEW OF STORED DEVICE MEMORY REVEALED LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS LESS THAN 20 OHMS DURING DELIVERY OF APPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY. AN INVASIVE PROCEDURE WAS PERFORMED. THE DEVICE WAS EXPLANTED AND REPLACED AND THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426222 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L| R 0175| E110| 4135