BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST JUDE MEDICAL / ABBOTT MEDICAL

    MDR report key: 8424830 · Received March 14, 2019

    Report

    Report Number
    MW5084929
    Event Type
    Injury
    Date Received
    March 14, 2019
    Date of Event
    February 2, 2018
    Report Date
    March 4, 2019
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(6) IMPLANTED AN ICD IN MY CHEST IN 2014. IN 2016 THAT ICD AND 400,000 OTHER ABBOTT ICDS WERE SUBJECT TO A CLASS 1 RECALL. ANOTHER RECALL FOLLOWED IN 2017. (B)(6) HID THOSE RECALLS FROM ME. (B)(6) 2016 OFFICE VISIT. ADVISORY APPEARS IN NOTES FIRST TIME. SILENCE ON RECALL. OCTOBER 10, 2016 ST. JUDE / FDA ISSUES CLASS 1 RECALL. ABBOTT REP WHO CAME TO (B)(6) AND "ASSISTED IN EVALUATING" ME ALSO HID THIS INFO FROM ME. IN RETROSPECT, I WOULD SAY THEY SEEMED TO HAVE SOME SORT OF AGREEMENT TO DO SO. (B)(6) WERE INTENTIONAL IN FAILING TO COMMUNICATE RECALL INFO TO PTS. THEY WERE ALSO NEGLIGENT IN NOT DEVELOPING AND IMPLEMENTING A RECALL COMMUNICATION STRATEGY. THEIR ACTIONS WERE VERY CALLOUS IN PUTTING MY LIFE AT RISK. I PAID THEM A SUBSTANTIAL AMOUNT OF MONEY TO PROVIDE PROTECTION FOR MY HEART AND LIFE. I BELIEVE IT WAS IN THEIR BEST INTERESTS (DUE TO THEIR MUTUALLY BENEFICIAL BUSINESS ALLIANCE WITH ABBOTT) TO NOT INFORM ME OF THE DANGERS I FACED. THEREFORE I DID NOT KNOW ABOUT: THE NEED TO HAVE A FIRMWARE UPDATE CONTAINING A BATTERY DEPLETION WARNING; THE WARNING I WOULD RECEIVE; THE NEED TO HAVE MY ICD MONITORED ON A DAILY BASIS; AND THE NEED TO STAY CLOSE TO EXPERT MEDICAL CARE. WHILE RESEARCHING MY FAILING ICD LEADS IN (B)(6) 2018 I FOUND OUT ABOUT THE RECALLS. MY BATTERY STARTED EARLY DEPLETION AND MY ICD WAS REPLACED ON (B)(6) 2018. (B)(6) 2017 OFFICE VISIT. ADVISORY SJM - EARLY BATTERY DEPLETION APPEARS IN NOTES 1ST TIME. SILENCE ON RECALLS. AUGUST 2017 ST. JUDE / FDA ISSUES 2ND CLASS 1 RECALL: FIRMWARE UPDATE ORDERED BY FDA, IT MUST TAKE PLACE IN DRS OFFICE. PT ICD WAS TO BE SHUT DOWN FOR DOWNLOAD AND INSTALL. (B)(6) 2017 OFFICE VISIT. (B)(4) FROM ABBOTT IN OFFICE, "CAME IN ROOM TO HELP EVALUATE." SILENCE ON RECALLS. OCTOBER 19, 2018 FDA ISSUES RECALL NOTICE UPDATE. NOVEMBER 7, 2017 OFFICE VISIT. REDUCED PACING TO 50 BPM. SILENCE ON RECALLS. (B)(6) 2018 OFFICE VISIT. (B)(6) BREAKS SILENCE IN RESPONSE TO PT FINDINGS, PROCLAIMING, "ADVISORY EDUCATION COMPLETED." DATES OF USE: (B)(6) 2014 TO (B)(6) 2018. DIAGNOSIS OR REASON FOR USE: ARVD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212413 ST JUDE MEDICAL / ABBOTT MEDICAL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ABBOTT LABORATORIES CD2257-40

    Patients

    Seq Age Sex Outcome Treatment
    0 61 YR Life Threatening