BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II PLUS DR

    MDR report key: 1831004 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03670
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 16, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMMUNICATION ANOMALY WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO A LOW BATTERY VOLTAGE. BASED ON DEVICE SETTING INFORMATION DURING THE FOLLOW-UP 3 MONTHS PRIOR TO EXPLANT, THE DEVICE DID NOT PERFORM TO THE EXPECTED LONGEVITY. DIRECT MEASUREMENT OF CURRENT DRAIN AFTER OPENING THE DEVICE FOUND HIGH CURRENT; HOWEVER, FURTHER TESTING TO ISOLATE THE HIGH CURRENT DRAIN WAS NOT SUCCESSFUL, AS THE HIGH CURRENT STATE WAS LOST DURING THE ANALYSIS. THE ORIGINAL BATTERY WAS SENT TO THE VENDOR FOR FURTHER EVALUATION; NO ANOMALY WAS DETECTED. THE CAUSE OF THE PREMATURE BATTERY DEPLETION WAS HIGH CURRENT DRAIN, THOUGH THE CAUSE FOR THE HIGH CURRENT ANOMALY WAS NOT DETERMINED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE PRODUCT ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A SHAFT KINK OCCURRED. THE 85% STENOTIC LESION WAS LOCATED IN THE MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN DILATED THE LESION WITH A 1.5X15MM UNSPECIFIED BALLOON. THEN THE PHYSICIAN BEGAN THE INTRODUCTION OF THE 2.5X24MM TAXUS LIBERTE STENT INTO THE PATIENT AND OBSERVED THAT THE SHAFT HAD FOLDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.5X24MM TAXUS LIBERTE STENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THE SHAFT WAS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP, NO COMMUNICATION COULD BE ESTABLISHED WITH THE DEVICE. HENCE, THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS II PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-268

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention