BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUIDENT ENDOTAK

    MDR report key: 219127 · Received April 14, 1999

    Report

    Report Number
    MW1016131
    Event Type
    Other
    Date Received
    April 14, 1999
    Date of Event
    March 31, 1999
    Report Date
    April 5, 1999
    Manufacturer
    CARDIAC PACEMAKERS, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED 6/7/99: INFO INDICATES THE ENDOTAK LEAD REMAINS IMPLANTED AND IN SERVICE. THE PT IS A PARTICIPANT IN A SCIENTIFIC STUDY. DURING AN EXAM THE PHYSICAIN HEARD A RUBBING SOUND. AN ECHO DOPPLER WAS PERFORMED, AND THE PHYSICIAN DETERMINED THAT THE LEAD WAS NOT AT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDENT ENDOTAK Implant PACING SHOCKING LEAD LWS CARDIAC PACEMAKERS, INC. 0134 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other