BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET TIP BIPOLAR LEAD

    MDR report key: 94158 · Received March 6, 1997

    Report

    Report Number
    2124215-1997-00987
    Event Type
    Injury
    Date Received
    March 6, 1997
    Date of Event
    November 30, 1996
    Report Date
    December 10, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THESE TWO SWEET TIP BIPOLAR LEADS (4269'S) WERE REMOVED FROM SERVICE AND CAPPED, DUE TO NON-CAPTURE. AFTER SEVEN DAYS AND INVASIVE PROCEDURE WAS PERFORMED AND THE (4269 258985) LEAD WAS CAPPED. A NEW (4269 251595) LEAD WAS IMPLANTED. THIS LEAD ALSO WAS REMOVED FROM SERVICE AND CAPPED AFTER ONLY FIVE DAYS OF IMPLANT, DUE TO THE LEAD TIP (HELIX) NOT ADEQUATELY FIXATING. A NEW LEAD WAS IMPLANTED (4316) ALONG WITH A MEDTRONIC LEAD.

    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 31 MO Required Intervention THE DEVICE 4316/200160 WAS IMPLANTED 25-NOV-1996