BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT VR

    MDR report key: 1223629 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03583
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 7, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD EVENT OF NOISE WAS CONFIRMED. THE DEVICE WAS CONNECTED TO TEST LEADS AND PLACED IN SALINE. THE DEVICE HEADER WAS RUBBED AND TAPPED ON REPEATEDLY. NO NOISE WAS OBSERVED ON THE REAL-TIME EGM WHEN TEST LEADS WERE SECURELY FASTENED. HOWEVER, WHEN THE V-TIP SETSCREW WAS LOOSENED TO FORM AN INTERMITTENT CONNECTION, NOISE WAS SEEN ON TEH EGM. THE DEVICE FUNCTIONED NORMALY ON THE BENCH AND DURING TESTING. NO ANOMALIES WERE DETECTED. IT IS POSSIBLE THAT THE CAUSE OF THE NOISE WAS DUE TO A CONNECTION ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD NOISE WAS OBSERVED ON THE DEVICE EGMS. HIGH LEAD IMPEDANCE WAS ALSO NOTED. A HEADER/ SETSCREW ISSUE WAS SUSPECTED. THE NOISE AND IMPEDANCE ANOMALY WERE RESOLVED WHEN THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1107-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention