BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1771212 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12132
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    April 23, 2010
    Report Date
    June 4, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT BOSTON SCIENTIFIC, CRM'S POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. THE RV OUTER PORT IS IN SPECIFICATION AND SPRING CONNECTORS MEET SPECIFICATION. THE SET SCREWS WERE VISUALLY INSPECTED AND ALL OPERATE NORMALLY. THE DEVICE WAS THEN SUBJECTED TO A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFY THE PERFORMANCE OF THE DEFIBRILLATION, PACING SENSING, HIGH VOLTAGE SHOCKING AND RECORDING FUNCTIONS OF THE DEVICE. THE DEVICE PERFORMED NORMALLY THROUGHOUT ALL TESTS. ANALYSIS COULD NOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE PHYSICIAN EXPERIENCED DIFFICULTY INSERTING THE CHRONIC RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD INTO THIS DEVICE HEADER. SEVERAL ATTEMPTS WERE MADE. THE RATE/SENSE PIN POPPED OUT OF THE PORT (PISTON EFFECT) REPEATEDLY AND A SECURE CONNECTION COULD NOT BE ESTABLISHED. STERILE WATER WAS USED WITHOUT SUCCESS AND MINERAL OIL WAS SUGGESTED. HOWEVER, THE PHYSICIAN ELECTED TO IMPLANT A NEW DEVICE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    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 79 YR E110| T165| 4470| 0185| MISMATCH