BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3901195 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12672
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 5, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 APPROXIMATELY THREE WEEKS POST IMPLANT, THE PATIENT LOST CONSCIOUSNESS AND REQUIRED REANIMATION. THE PATIENT WAS TREATED AT A DIFFERENT, UNNAMED HOSPITAL. AT THAT TIME, TACHY THERAPIES WERE PROGRAMMED OFF PER FAMILY REQUEST. THE PATIENT DID NOT REGAIN CONSCIOUSNESS AND REMAINED IN NURSING CARE UNTIL (B)(6) 2014 WHEN HE WAS BROUGHT TO THE HOSPITAL FOR TREATMENT DUE TO ASPIRATION. HIGH CAPTURE THRESHOLD WAS NOTED AND FLUOROSCOPY OF THE LEAD REVEALED PERFORATION. THE DOCTOR STATED THE REASON FOR REANIMATION WAS UNKNOWN. IT WAS ALSO STATED THAT IT WAS UNKNOWN WHETHER THE PERFORATION RESULTED IN THE NEED FOR REANIMATION OR WHETHER THE PERFORATION WAS CAUSED BY THE REANIMATION PROCEDURE. THE PATIENT WAS TRANSFERRED BACK TO NURSING CARE FOLLOWING TREATMENT FOR THE ASPIRATION, AND REMAINS IN AN UNCONSCIOUS STATE. THE SYSTEM REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379623 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| S CD1259-40Q, 1060872