BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2041452 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01202
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 27, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE PRODUCTS REMAIN 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

    IT WAS LATER REPORTED THAT THE PATIENT WAS SCHEDULED TO BE FURTHER EVALUATED.

    Additional Manufacturer Narrative · 1

    FURTHER TROUBLESHOOTING WAS PERFORMED AND RISING THRESHOLD WERE ALSO NOTED. AN X-RAY CONFIRMED THE PIN STATUS. BASED ON THE OUTCOME THE PHYSICIAN ALLEGED A LEAD FRACTURE WAS OCCURRING. IT IS UNKNOWN IF OR WHEN A LEAD REVISION WOULD BE PERFORMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED HIGH PACING IMPEDANCES ON THIS DEFIBRILLATION LEAD. NO ADVERSE PATIENT EFFECTS WERE 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 58 YR 1790| 0147| 1852| E102