BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2170291 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09642
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 7, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE NON-BSC RIGHT VENTRICULAR (RV) LEAD SHOCK IMPEDANCE MEASUREMENT CONTINUED TO FLUCTUATE, INCREASING TO GREATER THAN 125 OHMS. THE PATIENT WAS TO BE BROUGHT IN FOR NON-INVASIVE PROGRAMMED STIMULATION (NIPS) TESTING, HOWEVER, DEVELOPED HEART FAILURE AND TESTING WAS POSTPONED. AN RV LEAD FRACTURE WAS SUSPECTED. IT WAS NOTED THAT THE NON-BSC RV LEAD WAS PROGRAMMED TO A SINGLE COIL CONFIGURATION, WHICH MAY HAVE BEEN CONTRIBUTING TO THE OUT OF RANGE MEASUREMENTS. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    APPROXIMATELY FIVE MONTHS LATER, AN INCREASED SHOCK IMPEDANCE MEASUREMENT WAS AGAIN OBSERVED TO BE GREATER THAN 125 OHMS. THE SALES REPRESENTATIVE REPORTED THAT THE PATIENT WAS TO BE CLOSELY MONITORED. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE SYSTEM DECLARED AN INCREASED SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS. IT WAS REPORTED THAT THE SYSTEM WAS PROGRAMMED TO A SINGLE COIL CONFIGURATION. THE HEALTH CARE PROVIDER (HCP) PLANNED TO REVIEW THE DEVICE DATA AND CONTINUE TO MONITOR. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR (B)(4)| (B)(4)