BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2173233 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10851
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    August 11, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED AS NECESSARY.

    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 BECAME AVAILABLE THAT HIGH OUT OF RANGE SHOCK IMPEDANCES HAVE ONCE AGAIN BEEN SEEN ON THIS LEAD. TO DATE, THE LEAD REMAINS IMPLANTED AND THE PHYSICIAN PLANS TO MONITOR THE PATIENT FOR NOW, NO INTERVENTIONS DONE OR PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THE LEAD CHECKED OUT FINE AND NO SURGICAL INTERVENTION WAS PERFORMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED A RIGHT VENTRICULAR LEAD HIGH OUT OF RANGE SHOCKING IMPEDANCE OF GREATER THAN 125 OHMS. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    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 48 YR E102| 0180