BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT DR

    MDR report key: 1050880 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01822
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 20, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF VARYING T-WAVE MEASUREMENTS COULD NOT BE CONFIRMED IN THE LABORATORY. THE DEVICE VENTRICULAR PACING OUTPUT WAVEFORM AND R-WAVE MEASUREMENTS WERE VERIFIED ON THE BENCH TO FUNCTION NORMALLY. THE DEVICE ALSO PERFORMED NORMALLY DURING AUTOMATED TESTING. IT IS POSSIBLE THAT R-WAVE MEASUREMENTS VARIED DUE TO A LEAD RELATED ISSUE. THE DEVICE WAS FOUND TO BE NORMAL.

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLE PROCEDURE, THE FIRST DEVICE WAS STUCK ON THE DUCT AND THEY HAD TO PULL IT OFF. THE SECOND DEVICE WAS STUCK ON THE DUCT AND HAD TO BE PULLED OFF THE DUCT. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCE, BUT THEY DID NOT KNOW HOW IT WAS COMPLETED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REMOVED DUE TO A CAPTURE ANOMALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2107-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention