BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II HF CRT-D

    MDR report key: 1572900 · Received January 8, 2010

    Report

    Report Number
    2017865-2010-00713
    Event Type
    Injury
    Date Received
    January 8, 2010
    Date of Event
    October 8, 2009
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE FIELD EVENT WAS VERIFIED IN THE LABORATORY. THE DEVICE WAS FOUND TO BE OUTSIDE OF THE NORMAL LONGEVITY PERFORMANCE. AN EXTERNAL POWER SUPPLY WAS CONNECTED TO THE DEVICE. THE DEVICE MEASURED NORMAL CURRENT DRAIN. NO ANOMALIES WERE OBSERVED. THE DEVICE WAS TEMPERATURE CYCLED AND EXPOSED TO HUMIDITY FOR ONE WEEK. NO HIGH CURRENT ANOMALIES WERE DETECTED. THE DEVICE'S BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER ANALYSIS. NO ANOMALIES WERE DETECTED. THE CAUSE OF THE PREMATURE BATTERY DEPLETION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE DEVICE WAS EXPLANTED DUE TO EARLY ERI.

    Description of Event or Problem · 1

    ON (B) (6) 2009, I WAS PREPARING TO CHANGE THE PAD COVERING AN AREA WHICH WAS THE RESULT OF CANCER SURGERY. I PULLED OUT A 3"X3" STERILE PAD AND DISCOVERED A FLY HAD BEEN SEALED IN THE STERILE PAD. I TOOK PICTURES ON THAT DAY AND MADE A VIDEO, TOO. I DID NOT USE ANYMORE FROM THAT BOX. I CONTACTED MY ATTORNEY AND TALKED WITH HIM. THERE HAS BEEN A LOT GOING ON IN OUR FAMILY, SO I PUT THE BOX ASIDE KNOWING I NEEDED TO FOLLOW UP ON IT AT A LATER DATE. ON FEBRUARY 3, I CONTACTED ASSOCIATED (B) (4). AND SPOKE WITH (B) (4). I GAVE HER THE NUMBERS ON THE PAD AND ALSO EMAILED PICTURES TO HER. (B) (4) FOLLOWED UP WITH A LETTER DATED 2/4/2010. SHE TOLD ME I WOULD RECEIVE A RESPONSE FROM THEIR SUPPLIER (B) (4). ON 2/11/2010, I RECEIVED A LETTER FROM ASO, LLC. THE FOLLOWING QUOTE IS FROM ASO'S LETTER: "WE HAVE STARTED INVESTIGATING FOR THE ROOT CAUSE OF YOUR FINDINGS. OUR QA DEPARTMENT IS GOING TO INVESTIGATE IF WE HAVE INVENTORY FOUND. WE WOULD LIKE TO REQUEST THAT YOU RETURN TO US THE PRODUCT FOR OUR EXAMINATION IN OUR LAB. A PRE ADDRESSED POSTAGE PAID ENVELOPE IS PROVIDED FOR YOUR CONVENIENCE. ONCE WE RECEIVE THE PRODUCT BACK, AND COMPLETE OUR INVESTIGATION, WE WILL INFORM YOU OF OUR FINDINGS." AFTER READING THE LETTER, I CALLED THE ATTORNEY GENERAL'S OFFICE IN (B) (4) AND SPOKE WITH THEIR CONSUMER GROUP. THEY SUGGESTED I CALL THE (B) (4) HEALTH DEPT. WHICH I DID AND I SPOKE WITH (B) (6). HE GAVE ME THE FDA NUMBER TO CALL IN (B) (4). I CALLED THE NUMBER AND LEFT A MESSAGE AND (B) (4)-. HE RETURNED MY CALL AND SUGGESTED THAT I FILE THIS REPORT. THE PADS WERE MADE IN (B) (4). I HAVE DEALINGS IN (B) (4) AND UNDERSTAND QUALITY CONTROL CAN BE AN ISSUE. MY CONCERN IS FOR THE PUBLIC'S SAFETY. HOW DOES A FLY GET SEALED INTO A STERILE PAD ... MORE IMPORTANTLY, IS HOW DOES A FLY GET INTO A STERILE MANUFACTURING PLANT? I CAN SEND YOU THE PICTURES AND LETTERS. I WILL NOT RESPOND TO ASO UNTIL I HEAR BACK FROM YOUR OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS II HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-365 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention