BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1640002 · Received March 25, 2010

    Report

    Report Number
    2649622-2010-00582
    Event Type
    Death
    Date Received
    March 25, 2010
    Date of Event
    January 17, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. FOLLOW UP REVEALED THAT A SUBCLAVIAN PUNCTURE HAD BEEN THE INTRODUCTION TECHNIQUE FOR ACCESSING THE VEINS FOR LEAD INTRODUCTION. NO AUTOPSY WAS PERFORMED; HOWEVER, THERE IS NO ALLEGATION FROM THE PHYSICIAN AGAINST THE DEVICE OR LEADS AS REGARDS THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS DISCHARGED FROM HOSPITAL 3 DAYS AFTER DEVICE IMPLANT WITH NO SIGNS OF PERICARDIAL EFFUSION, PLEURAL EFFUSION, OR BLEEDING IN DEVICE POCKET. PATIENT STARTED ON ANTICOAGULATION THERAPY (B) (6) 2010 DUE TO REDUCED LV FUNCTION, PREVIOUS STROKE, (B) (6) ,AND PAROXYSMAL ATRIAL FIBRILLATION. PATIENT ADMITTED TO INTENSIVE CARE UNIT (B) (6) 2010 DUE TO DYSPNEA. CHEST XRAY SHOWED LEFT LUNG "COMPLETELY SHADOWED WITH FLUID." ECHOCARDIOGRAM SHOWED "SMALL, HEMODYNAMICALLY NOT RELEVANT PERICARDIAL EFFUSION." BLEEDING IN THE DEVICE POCKET ALSO REPORTED - CT OF THORAX SHOWED HEMOTHORAX ON LEFT. "THORACAL DRAIN" INSERTED AND REMOVED 750ML HEMORRHAGIC FLUID. PATIENT IMPROVED TEMPORARILY, BUT AGAIN WORSENED REQUIRING 2ND DRAINAGE. PATIENT DID NOT IMPROVE WITH THIS AND EMERGENCY THORACOTOMY PERFORMED. EVEN WITH CATECHOLAMINE SUPPORT, PATIENT WORSENED, REQUIRED 2ND THORACOTOMY, BUT DIED INTRAOPERATIVELY. CAUSE OF DEATH REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS DISCHARGED FROM HOSPITAL 3 DAYS AFTER DEVICE IMPLANT WITH NO SIGNS OF PERICARDIAL EFFUSION, PLEURAL EFFUSION, OR BLEEDING IN DEVICE POCKET. PATIENT STARTED ON ANTICOAGULATION THERAPY (B) (6) 2010, DUE TO REDUCED LV FUNCTION, PREVIOUS STROKE, AGE GREATER THAN (B) (6), AND PAROXYSMAL ATRIAL FIBRILLATION. PATIENT ADMITTED TO INTENSIVE CARE UNIT (B) (6) 2010, DUE TO DYSPNEA. CHEST XRAY SHOWED LEFT LUNG "COMPLETELY SHADOWED WITH FLUID." ECHOCARDIOGRAM SHOWED "SMALL, HEMODYNAMICALLY NOT RELEVANT PERICARDIAL EFFUSION." BLEEDING IN DEVICE POCKET REPORTED - CT OF THORAX SHOWED HEMOTHORAX ON LEFT. "THORACAL DRAIN" INSERTED AND REMOVED 750ML HEMORRHAGIC FLUID. PATIENT IMPROVED TEMPORARILY, BUT AGAIN WORSENED REQUIRING 2ND DRAINAGE. PATIENT DID NOT IMPROVE WITH THIS AND EMERGENCY THORACOTOMY PERFORMED. EVEN WITH CATECHOLAMINE SUPPORT, PATIENT WORSENED, REQUIRED 2ND THORACOTOMY, BUT DIED INTRAOPERATIVELY. CAUSE OF DEATH REQUESTED, NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death