BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICKFLEX XL LV LEAD

    MDR report key: 6215904 · Received December 30, 2016

    Report

    Report Number
    2938836-2016-24009
    Event Type
    Death
    Date Received
    December 30, 2016
    Date of Event
    July 2, 2016
    Report Date
    December 1, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THE CAUSE OF DEATH WAS ACUTE RESPIRATORY FAILURE, CARDIAC ARRHYTHMIA, VENTRICULAR TACHYCARDIA, CARDIOMYOPATHY, AND CORONARY ARTERY DISEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THE PATIENT WAS ADMITTED WITH ACUTE KIDNEY INJURY AND HYPOGLYCEMIA. DURING ADMISSION THE PATIENT HAD VENTRICULAR TACHYCARDIA EPISODES WITH HEMODYNAMIC INSTABILITY AND ALTERED MENTAL STATUS. A VT ABLATION WAS DONE ON (B)(6) 2016. THE PATIENT DID WELL UNTIL (B)(6) 2016 WHEN HE DEVELOPED VT THAT DEGENERATED TO VENTRICULAR FIBRILLATION AND WAS SHOCKED 3 TIMES. HE CONTINUED TO HAVE VT AND TREATED WITH AN AMIODARONE DRIP. PATIENT WAS CHANGED TO COMFORT MEASURES ONLY AND EXPIRED ON (B)(6) 2016. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866644 QUICKFLEX XL LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1158T/86 0002130678

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death (B)(4)| (B)(4)