BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERVENE LEAD

    MDR report key: 383434 · Received February 8, 2002

    Report

    Report Number
    2124215-2002-03662
    Event Type
    Malfunction
    Date Received
    February 8, 2002
    Date of Event
    October 1, 2001
    Report Date
    October 1, 2001
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS INTERMEDICS LEAD HAD ELEVATED IMPEDANCE READINGS. THE PATIENT HAD JUST HAD A BATTERY CHANGEOUT APPROXIMATELY 3 MONTHS EARLIER. INFORMATION FROM SR INDICATED LEAD FRACTURE. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERVENE LEAD IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS 497-23 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other THE DEVICE 0154/349020 WAS IMPLANTED 01-OCT-2001| THE DEVICE 1860/103919 WAS IMPLANTED 14-JUN-2001