BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY DR

    MDR report key: 3101147 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-01926
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    February 26, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF NOISE DUE TO CROSSTALK AND A REDUCTION OF R-WAVE AMPLITUDE WERE NOT CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND MET ALL TEST SPECIFICATIONS. NO ANOMALY WAS OBSERVED. NO NOISE WAS OBSERVED ON REAL-TIME ELECTROGRAMS. THE SENSED AMPLITUDES WERE NORMAL WHEN APPLIED TO THE INPUT SIGNAL. THE CAUSE OF THE REPORTED FIELD EVENTS WERE NOT DETERMINED.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THE DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED INAPPROPRIATE THERAPY AROUND THE TIME THE PATIENT WAS IN THE HOSPITAL FOR PNEUMONIA AND ON LEVAQUIN. CROSSTALK WAS OBSERVED FOR THOSE EPISODES. PATIENT DID NOT HAVE ANY MORE EPISODE AFTER THAT AND NO FURTHER CROSSTALK. THE PHYSICIAN PLANS TO FLUORO THIS DEVICE AND LEAD WHEN ERI IS REACHED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES REDUCED R-WAVE AMPLITUDES WERE OBSERVED. THE PHYSICIAN SUSPECTED THE DEVICE AND THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203702 FORTIFY DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention