BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOTON MICRO VR

    MDR report key: 1523963 · Received November 10, 2009

    Report

    Report Number
    2017865-2009-03897
    Event Type
    Injury
    Date Received
    November 10, 2009
    Date of Event
    September 18, 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

    THE REPORTED ANOMALY OF RESET WAS VERIFIED IN THE LABORATORY. TWO ARC MARKS WERE OBSERVED ON THE ICD CAN. IT IS BELIEVED THAT THE LEAD ARCED TO THE CAN DURING HIGH VOLTAGE THERAPY. DURING A SUBSEQUENT HIGH VOLTAGE EVENT, THE DEVICE RESET.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WENT INTO BACK-UP MODE. THE DEVICE WAS EXPLANTED AND REPLACED.

    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 PHOTON MICRO VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-194 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention