BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4131629 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-16510
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    June 26, 2013
    Report Date
    July 14, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPEAT BLOOD CULTURES IN (B)(6) 2013 CONTINUED TO TEST POSITIVE, THEREFORE THE PATIENT WAS READMITTED TO THE HOSPITAL FOR FURTHER EVALUATION OF HIS PERSISTENT BACTEREMIA. THE ANTIBIOTIC REGIMEN WAS SWITCHED AND A REPEAT TRANS-ESOPHAGEAL ECHO SHOWED EVIDENCE OF INFECTION ON THE TRICUSPID VALVE AS WELL THE DEFIBRILLATION LEAD. THE PATIENT WAS THEN TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER EVALUATION. HE THEN UNDERWENT EXTRACTION OF HIS ICD SYSTEM ON (B)(6) 2013. THE PROCEDURE WAS COMPLICATED BY HEMODYNAMIC COMPLICATIONS REQUIRING PRESSER SUPPORT AND INTUBATION FOR A LARGE PLEURAL EFFUSION. THE PATIENT DEVELOPED ACUTE KIDNEY INJURY DURING THE HOSPITALIZATION AND WAS DIURESED ACCORDINGLY. THE PATIENT THEN DEVELOPED A HEMATOMA IN THE ICD POCKET FOLLOWING THE EXPLANT PROCEDURE WITH AN INITIAL DROP IN THE HEMATOCRIT AND HEMOGLOBIN. THE PATIENT WAS KEPT WITHOUT EXTERNAL PACING. BLOOD CULTURES STAYED NEGATIVE SINCE ADMISSION. THE PATIENT HAD ALSO BEEN RECENTLY DIAGNOSED WITH SMALL CELL CARCINOMA. AN MRI OF THE BRAIN SHOWED NO METASTASIS. THE PATIENT STAYED AFEBRILE AND NO LEUKOCYTOSIS WAS NOTED DURING HOSPITALIZATION. ALL BLOOD CULTURES CONTINUED TO BE NEGATIVE AND THE PATIENT WAS DISCHARGED ON FROM THE HOSPITAL (B)(6) 2013 AND SENT HOME WITH A LIFE-VEST UNTIL ANOTHER ICD PLACEMENT. SOME TIME AFTER THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND CLEARED FROM INFECTION, THE PATIENT PASSED AWAY. INVESTIGATION INTO THE CAUSE OF DEATH IS NOT KNOWN AT THIS TIME; HOWEVER THERE HAVE BEEN NO REPORTED ALLEGATIONS FROM ANY MEDICAL PERSONNEL. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED A CALL FROM THE PATIENT'S SPOUSE STATING SHE RECEIVED A LETTER NEEDING TO UPDATE INFORMATION FROM BOSTON SCIENTIFIC. IN HER RESPONSE, SHE INFORMED US THAT HER HUSBAND HAD PASSED AWAY AND STATED OUR DEVICE KILLED HIM. THE PATIENT WAS IMPLANTED WITH A COMPETITOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), BUT HAD A BOSTON SCIENTIFIC DEFIBRILLATION LEAD. ADDITIONAL INVESTIGATION WAS PERFORMED IN WHICH BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT UNDERWENT AN ICD LEAD REPLACEMENT ON (B)(6) 2013 DUE TO A COMPETITOR LEAD MALFUNCTION. THE REPLACEMENT PRODUCT WAS A BOSTON SCIENTIFIC ICD LEAD. ACCORDING TO MEDICAL RECORDS OBTAINED, THE PATIENT HAD A HISTORY OF CORONARY ARTERY DISEASE, STATUS POST STENTS IN LAD AND LCA, AND ICD PLACEMENT FOR IDIOPATHIC VENTRICULAR TACHYCARDIA 10 YEARS AGO, ALSO WITH HYPERTENSION, GOUT, ATRIAL FIBRILLATION, TYPE 2 DIABETES AND NON-ISCHEMIC CARDIOMYOPATHY. TWO WEEKS FOLLOWING THIS PROCEDURE, THE PATIENT PRESENTED BACK WITH A STAPH INFECTION AND WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. AT THAT TIME, THE PATIENT ALSO UNDERWENT A CATHETERIZATION WITH THE PLACEMENT OF STENTS IN HIS LAD AND LCA. THE PATIENT WAS THEN DISCHARGED WITH INTRAVENOUS ANTIBIOTICS AND ADDITIONAL MEDICATIONS FOR 3-4 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612067 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R MISMATCH| 1571| 0295| 1342T