BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST. JUDE MEDICAL ICD 'CURRENT RF-DR'

    MDR report key: 1702683 · Received May 18, 2010

    Report

    Report Number
    MW5016115
    Event Type
    Death
    Date Received
    May 18, 2010
    Date of Event
    October 25, 2009
    Report Date
    May 18, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT IS NOT KNOWN WITH 100% CERTAINTY THAT THE ICD LEAD WIRE PUNCTURING THE HEART WAS DUE TO PRODUCT DEFECT OR DESIGN OR IF IT WAS A PROCEDURAL ISSUE AS NO AUTOPSY WAS PERFORMED. HOWEVER, IT IS OUR FAMILY'S BELIEF THAT THE HEART PUNCTURE AND DELAY OF CARE AFTERWARDS CERTAINLY CONTRIBUTED TO CONTRACTION OF PNEUMONIA AND HIS SUBSEQUENT DEATH. THE EVENTS ARE AS FOLLOWS: ON (B) (6) 2009: HE HAD ST JUDE IMPLANTABLE CARDIOVERTER - DEFIBRILLATOR (BRAND NAME 'CURRENT RF-DR') SURGERY AT A (B) (4) HOSPITAL WITHOUT APPARENT COMPLICATION. ON (B) (6) 2009: HE WAS RELEASED FROM THE AFOREMENTIONED HOSPITAL. HE BEGAN TO COMPLAIN OF BEING "SHOCKED" BELOW THE HEART ON THE LEFT SIDE AT THE RIB AREA. AFTER MULTIPLE VISITS TO CARDIOLOGISTS WITHIN ONE WEEK'S TIME, THE TECHNICIAN SAID HIS ICD DID NOT "GO OFF" MEANING IT DID NOT INDICATE THAT IT HAD DELIVERED A SHOCK HIS HEART. ON (B) (6) - (B) (6) 2010: HE WENT TO A LOCAL EMERGENCY ROOM COMPLAINING OF "BEING SHOCKED" AND "SEVERE CHEST PAIN". HE WAS DISCHARGED HOME EACH VISIT. ON (B) (6) 2009: HE RETURNED TO ORIGINAL HOSPITAL WHERE IT WAS DETERMINED THAT THE LEAD WIRE TO THE ICD HAD PUNCTURED HIS LEFT VENTRICLE AND WAS SHORTING-OUT AT HIS RIB. ON (B) (6) 2009: HE HAD SURGERY TO REPOSITION THE LEAD WIRE. ON (B) (6) 2009: HE WAS RELEASED FROM THE HOSPITAL. ON (B) (6) 2009: HE CALLED HIS PRIMARY CARE DOCTOR WITH THE COMPLAINT OF LABORED BREATHING. HE WAS SENT TO LOCAL HOSPITAL FOR CHEST X-RAY AND BLOOD WORK. ON (B) (6) 2009: PRIMARY DOCTOR SUSPECTS "TOUCH OF PNEUMONIA". ON (B) (6) 2009: HE IS ADMITTED TO LOCAL HOSPITAL AND WAS TREATED FOR PNEUMONIA. ON (B) (6) 2009: HE DIES AT HOSPITAL FROM CARDIAC ARREST SECONDARY TO PNEUMONIA AND ELECTROLYTE IMBALANCE. BELIEVED TO BE A SINGLE-USE DEVICE AND THEREFORE E9 SECTION BELIEVED TO BE NOT APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL ICD 'CURRENT RF-DR' IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR OR ICD LWS ST. JUDE MEDICAL ICD 2207-36
    2 ST. JUDE MEDICAL ICD 'CURRENT RF-DR' IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR OR ICD LWS ST. JUDE MEDICAL RA-LEAD 1688TC/52
    3 ST. JUDE MEDICAL ICD 'CURRENT RF-DR' IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR OR ICD LWS ST. JUDE MEDICAL RVA 7121/65

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| H| L| R