BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATLAS PLUS DR

    MDR report key: 1095763 · Received August 6, 2008

    Report

    Report Number
    2017865-2008-02604
    Event Type
    Death
    Date Received
    August 6, 2008
    Date of Event
    May 30, 2008
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE ANOMALY OBSERVED IN THE FIELD WAS NOT CONFIRMED IN THE LABORATORY. THE DEVICE MET ALL SPECIFICATIONS; NO ANOMALIES WERE DETECTED.

    Description of Event or Problem · 1

    THE DEVICE FAILED TO DETECT VF RHYTHM DURING DETECTION AND CHARGING FOR VT THERAPY. THE VF RHYTHM WAS DIAGNOSED VIA THE EXTERNAL MONITOR AND EXTERNAL DEFIBRILLATION WAS USED, WHICH WAS SUCCESSFUL. THE PATIENT HAD BEEN SICK PRIOR TO THE EVENT AND AFTER THE EVENT, THE PATIENT'S CONDITION DE- TERIORATED AND HE REMAINED HOSPITALIZED UNTIL DEATH A MONTH AFTER THE EVENT. IT IS UNKNOWN WHETHER OR NOT THE DEVICE CONTRIBUTED TO THE DETERIORATION OF THE PATIENT'S HEALTH.

    Description of Event or Problem · 1

    THIS COMPLAINT FILE ADDRESSES PRODUCT SAMPLE 5 OF 15 REPORTED 7/28/2010. DURING A FOLLOW UP CALL TO THE HOME PATIENT (HP) BY PRODUCT SURVEILLANCE, THE HP REPORTED THAT FOUR (4) CASSETTES WERE FOUND WITH THE TUBING CRUSHED AND UNUSABLE. ON (B)(4) 2010, PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO CONFIRMED THAT THE DAMAGED CASSETTES WERE NOT USED; THE DAMAGE WAS NOTED PRIOR TO THERAPY. ON (B)(4) 2010, PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED, THE EXTERNAL BOX OF THIS PRODUCT LOT WAS NOT DAMAGED. THE HP STATED APPROXIMATELY HALF OF THE CASE OF THE CASSETTES (15) HAD TO BE DISCARDED DUE TO CRUSHED TUBING. THE HP STATED, THE 15 CASSETTES HE DISPOSED OF ALL HAD 'U' SHAPE DAMAGE AND THE TUBING WAS UNUSABLE. THE HP STATED, THERE WERE A VARIETY OF LINES DAMAGED; THERE WAS NO TREND OF SPECIFIC LINE. HOWEVER, THE HP STATED ALL LINES WERE CRUSHED ABOVE THE CLAMPS. THE HP STATED, IT APPEARED THE CLAMPS CAUSED THE DAMAGE TO THE TUBING BY HOW THE CASSETTES WERE PACKAGED. THE HP STATED, HE HAS HAD NO ISSUE WITH HIS NEW LOT OF SUPPLIES AND HAS SELDOM HAD ISSUES WITH PRODUCT IN THE PAST. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-243 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| R