BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET TIP BIPOLAR LEAD

    MDR report key: 94119 · Received March 6, 1997

    Report

    Report Number
    2124215-1997-00951
    Event Type
    Injury
    Date Received
    March 6, 1997
    Date of Event
    November 29, 1996
    Report Date
    December 23, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT DURING AN IMPLANT PROCEDURE THIS BIPOLAR LEAD HAD DISLODGED. THE PHYSICIAN ELECTED TO WAIT UNTIL THE NEXT DAY TO REPOSITON THE LEAD, MULTIPLE ATTEMPTS TO SCREW IN THE LEAD FAILED. THE LEAD WAS REMOVED AND IT WAS FOUND THE SCREW WAS STRAIGHTENED. DUE TO THE PATIENT'S CONDITION NO NEW LEAD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET TIP BIPOLAR LEAD Implant BIPOLAR LEAD DXY CARDIAC PACEMAKERS 4269 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention