BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR ENDOCARDIAL LEAD

    MDR report key: 68959 · Received January 9, 1997

    Report

    Report Number
    2124215-1997-00118
    Event Type
    Malfunction
    Date Received
    January 9, 1997
    Date of Event
    August 8, 1996
    Report Date
    August 15, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT AN INVASIVE PROCEDURE WAS PERFORMED TO EXPLANT TWO BIPOLAR LEADS. THE BIPOLAR LEAD MODEL 4269 SERIAL 041300 WAS DISLODGED, THE PHYSICIAN TRIED TO REPOSITION THE LEAD BUT WAS NOT SUCCESSFUL. AT THE SAME PROCEDURE, THE BIPOLAR LEAD MODEL 4261 SERIAL 212997 WAS 'NICKED'. THE PHYSICIAN ELECTED TO REPLACE BOTH LEADS. IMPLANTED-06/23/94. EXPLANTED-08/08/96. IMPLANT MONTHS-25. THE PHYSICIAN'S MANUAL 352527-003C, PAGE 15, LISTS DISPLACEMENT AS AN ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR ENDOCARDIAL LEAD Implant BIPOLAR LEAD DTB CARDIAC PACEMAKERS 4261 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other THE DEVICE 0125/210676 WAS IMPLANTED 10-JUL-1996| THE DEVICE 1762/600184 WAS IMPLANTED 10-JUL-1996| THE DEVICE 4269/252196 WAS IMPLANTED 23-JUN-1996| THE DEVICE 1226/246401 WAS IMPLANTED 23-JUN-1994| THE DEVICE 4269/252511 WAS IMPLANTED 23-JUN-1996| THE DEVICE 4269/041300 WAS IMPLANTED 23-JUN-1994