BEUDAMED
    FDA Adverse Event Death Summary report: N

    FINELINE II

    MDR report key: 4909131 · Received July 13, 2015

    Report

    Report Number
    2124215-2015-09034
    Event Type
    Death
    Date Received
    July 13, 2015
    Date of Event
    April 9, 2015
    Report Date
    June 14, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PATIENT WAS FUTHER COMPLICATED WITH THE DEVELOPMENT OF CARDIOGENIC SHOCK, METABOLIC ACIDOSIS, ELEVATED LFT'S, AND PRESUMED SARCOID MYOCARDITIS, DILATED CARDIOMYOPATHY STATUS-POST CRT-D PLACEMENT. THE PATIENT WAS ON A BALLOON BUMP AND BEGAN TO IMPROVE, BUT THEN DECLINED WITH NOTED RENAL FAILURE LEADING TO CRRT ON (B)(6). THE PATIENT LATER RECEIVED ECMO ON (B)(6) AND THE BIVAD (MENTIONED ON (B)(6)). THE PATIENT DEVELOPED COAGULOPATHY, HYPERBILIRUBINEMIA AND A THROMBUS AT THE SINUSES OF VALSALVA. THE PATIENT CONTINUED TO DECLINE WITH COMPLETE RESPIRATORY FAILURE AND TRACHEOTOMY PLACEMENT. IN THE END, CULTURED POSITIVE FOR VRE, (B)(6) ENDOCARDITIS (TRICUSPID VALVE), AND CANDIDEMIA, ENTEROCOCCUS (URINE). THE PATIENT WAS MADE A DNR STATUS BY THE FAMILY AND PASSED AWAY.AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVELOPED AN INFECTION. IT WAS NOTED THAT THE LEAD (NOT SPECIFIED) WAS SHOWN TO BE GROWING ENTEROCOCCUS. THE CRT-D SYSTEM WAS EXPLANTED ON (B)(6) 2015. THE PATIENT DIED EIGHTEEN DAYS LATER. THE PRIMARY ORGAN CAUSE OF DEATH WAS UNKNOWN, BUT IT WAS NOTED THE PATIENT HAD ANTECEDENT WORSENING HEART FAILURE. THE PATIENT WAS TRANSFERRED OUT OF THE CLINICAL STUDY FOLLOWING REMOVAL OF THE CRT-D SYSTEM, THEREFORE DISPOSITION OF THE PRODUCTS WAS NOT KNOWN BY THE STUDY SITE. ADDITIONAL INFORMATION WAS PROVIDED WHICH INCLUDED PATIENT RECORDS FROM THE HOSPITAL WHERE THE PATIENT PASSED AWAY. THE PATIENT DIED IN THE ICU AT 20:23 ON (B)(6), 2015. NOTED IN THE CO-PATH REPORT (DATE (B)(6) 2015), THE PRELIMINARY ANATOMIC CAUSE OF DEATH WAS DILATED CARDIOMYOPATHY. THE PATIENT'S CRT-D SYSTEM WAS REMOVED (B)(6) 2015 ALONG WITH TRICUSPID VALVE SECONDARY TO BACTEREMIA AND ENDOCARDITIS, AND BIVAD PLACEMENT AT THAT TIME. THE PATIENT DIED WITH THE BIVAD IN PLACE. THE RHYTHM AT THE TIME OF DEATH WAS NOT NOTED. THE PATIENT BECAME HYPOTENSIVE WITH DECREASE MAP'S AND DECREASED FLOWS ON BIVAD IN THE CVTS DISCHARGE SUMMARY. OTHER CIRCUMSTANCES SURROUNDING THE DEATH WERE EXTENSIVE AND NOTED AS SUCH: CRT-D IMPLANT ON (B)(6) FOR HEART FAILURE. ON (B)(6), PATIENT TRANSFERRED HOSPITALS FOR CARDIAC BIOPSY AND PET SCAN TO RULE OUT CARDIAC SARCOIDOSIS (RESULTS NOT AVAILABLE). ON (B)(6), PATIENT RETURNED TO THE HOSPITAL AND ADMITTED TO ICU FOR CARDIOGENIC SHOCK, SECONDARY TO BI-VENTRICULAR FAILURE COMPLICATED BY VENTRICULAR TACHY STORM WITH SHOCKS FROM THE CRT-D. INTERROGATION OF DEVICE RESULTED IN NO PROGRAMMING CHANGES. STEROID TREATMENT WAS INITIATED WHERE THE PATIENT WAS THEN AIR-LIFTED TO ANOTHER HOSPITAL FOR ADVANCED HEART FAILURE CARE AND CONTINUED STEROID TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453998 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death| H| L| R 4671| 0696| 4543| N160| MISMATCH| 4592| 4470| 4672