BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET TIP

    MDR report key: 150616 · Received February 8, 1998

    Report

    Report Number
    2124215-1998-00311
    Event Type
    Injury
    Date Received
    February 8, 1998
    Date of Event
    November 3, 1997
    Report Date
    November 4, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED BECAUSE OF A HIGH P WAVE MEASUREMENTS AND AN ABNORMAL INCREASE IN VENTRICULAR PACING THRESHOLD. AN INSULATION DEFECT WAS ALSO NOTICED ON THE ATRIAL LEAD (MODEL 4269, SERIAL 260626). THIS LEAD WAS ALSO REPLACED. THE DEVICE IS INVOLVED IN A PRODUCT ADVISORY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention THE DEVICE 1821/200227 WAS IMPLANTED 03-NOV-1997| THE DEVICE 1810/300198 WAS IMPLANTED 05-DEC-1996| THE DEVICE 0125/206202 WAS IMPLANTED 05-DEC-1996