BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURRENT PLUS DR, DF-4 CONNECTOR

    MDR report key: 4173868 · Received October 15, 2014

    Report

    Report Number
    2938836-2014-16691
    Event Type
    Death
    Date Received
    October 15, 2014
    Date of Event
    December 15, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THE PATIENT HAD A HISTORY OF EMERGENCY ROOM VISITS DUE TO COPD, BRONCHITIS, PNEUMONIA, AND CHF. HE WAS ADVISED TO QUIT SMOKING. THE CLINIC LOST CONTACT WITH THE PATIENT AFTER SEPTEMBER 19, 2012. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PATIENT WHEN IN (B)(6) 2014, A FAMILY MEMBER REQUESTED ALL CONTACT TO STOP AS THE PATIENT HAD EXPIRED. RECORDS RETRIEVED BY THE CLINIC NOTED THAT THE PATIENT WAS ADMITTED IN (B)(6) 2012 FOR DYSPNEA, HYPOXIA, AND PNEUMONIA. IT WAS ALSO NOTED THAT THE PATIENT WAS ON AMIODARONE FOR RECURRENT CARDIAC ARRHYTHMIA. THE PHYSICIAN WAS NOT ABLE TO RETRIEVE PATIENT OR DEVICE INTERROGATION RECORDS, AND WAS UNABLE TO DETERMINE IF THE DEVICE HAD ANY RELATION TO THE PATIENT DEATH. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655659 CURRENT PLUS DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death 7122Q/BKA10490, 1888TC/CAC18373