BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3922002 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-13418
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    July 31, 2013
    Report Date
    August 1, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT VIA PATIENT REMOTE MONITORING SYSTEM, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE SHOCKING LEAD IMPEDANCE (SLI) MEASUREMENTS. LIKEWISE, THERE WAS AN INCREASED RV PACING THRESHOLDS FROM 0.8 VOLTS AT 0.5 MS TO 1.1 VOLTS AT 1.0 MS. HISTORY REVEALED THAT THE PATIENT RECEIVED SHOCKS FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE IMPEDANCE HAS BEEN HIGHER THAN NORMAL SINCE DEVICE REPLACEMENT. THE PATIENT WILL CONTINUE TO BE REMOTELY MONITORED FOR THE TIME BEING. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION WAS RECEIVED THAT HIGH SHOCKING LEAD IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS ON THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD SYSTEM WAS CONTINUED TO BE OBSERVED. ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED. AT THIS TIME THERE IS NO EVIDENCE THAT INTERVENTION HAS BEEN PERFORMED TO RESOLVE THIS ISSUE. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401019 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR T125| 0185| E110| 5076