BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS VR

    MDR report key: 1572927 · Received January 9, 2010

    Report

    Report Number
    2017865-2010-00686
    Event Type
    Injury
    Date Received
    January 9, 2010
    Date of Event
    November 25, 2009
    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

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    NOISE WAS CONFIRMED VIA REVIEW OF STORED EGMS. A POLISHED AREA WAS NOTED ON THE DEVICE CAN THAT IS USUALLY INDICATIVE OF A LEAD INSULATION BREACH. THE DEVICE'S FUNCTIONALITY WAS TESTED IN THE AUTOMATED TEST SYSTEM AND NO ANOMALIES WERE DETECTED. THE ASSOCIATED LEAD IS BELIEVED TO BE DAMAGED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE ON THE VENTRICULAR CHANNEL WAS OBSERVED. THE PHYSICIAN PHYSICALLY MANIPULATED THE LEAD AND COULD NOT REPRODUCE THE NOISE. THERE WERE NO SIGNIFICANT CHANGES IN THE LEAD MEASUREMENTS. A CONNECTION PROBLEM WAS SUSPECTED. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-199 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention