BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA XT VR

    MDR report key: 7093101 · Received December 7, 2017

    Report

    Report Number
    3004209178-2017-25332
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    April 1, 2017
    Report Date
    February 8, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    UDI-DI
    00643169017948
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION OF MEDICAL DEVICE: 6933110 LEAD, IMPLANTED:(B)(6) 1995. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED FEVERS AND WAS TREATED FOR A URINARY TRACT INFECTION. APPROXIMATELY TWO MONTHS LATER THE FEVER CAME BACK AND THE PATIENT ALSO HAD CHILLS. THE PATIENT UNDERWENT EXTENSIVE OUTPATIENT WORK FOR ABOUT THREE MONTHS WITH BLOOD CULTURES CONSISTENTLY COMING BACK NEGATIVE. AN ECHO-CARDIOGRAM SHOWED POSSIBLE VEGETATION ON A PREVIOUSLY INACTIVATED LEFT VENTRICULAR (LV) LEAD. THE PATIENT HAD ALSO DEVELOPED PROPIONIBACTERIUM ACNES. THE PATIENT WAS STARTED ON A SERIES OF ANTIBIOTICS. THE ANTIBIOTICS DID NOT ELIMINATE THE PATIENT'S FEVER AND A COMPLETE SYSTEM EXPLANT WAS SCHEDULED. THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT VENTRICULAR (RV) LEAD, AND PREVIOUSLY INACTIVATED LEFT VENTRICULAR (LV) LEAD WERE EXPLANTED. CULTURES REVEALED COCCOBACILLUS. AS THE PATIENT WAS EMERGING FROM ANESTHESIA FROM THE EXPLANT PROCEDURE, THE SURGICAL TEAM NOTED DYSARTHRIA AND LEFT UPPER EXTREMITY WEAKNESS. A COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED HYPOATTENUATION AND LOSS OF GRAY-WHITE MATTER JUNCTION INDICATING CYTOTOXIC EDEMA AT THE RIGHT PRECENTRAL GYRUS CONCERNING FOR ISCHEMIC INFARCT. NEUROLOGY RECOMMENDED THE PATIENT BE STARTED ON ASPIRIN FOR STROKE PROPHYLAXIS AND THE ALSO BELIEVED THE ISCHEMIA FITS WITH EMBOLISM, AND POSSIBLE VEGETATION THAT WAS RELEASED DURING THE SURGERY. A CT SCAN THE FOLLOWING DAY REVEALED OUTPOUCHING OF THE INNOMINATE ARTERY WITH SURROUNDING FAT STRANDING AND FLUID WHICH MAY REPRESENT AN INFECTIOUS PSEUDOANEURYSM. THE PATIENT UNDERWENT SURGERY THAT WAS DESCRIBED AS AORTA TO DISTAL INNOMINATE ARTERY BYPASS LIGATION OF INNOMINATE ARTERY WITH CULTURE OF TISSUE. INTER-OPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAPHY SHOWED VEGETATION AT THE SUPERIOR VENA CAVA (SVC)-RIGHT ATRIAL (RA) JUNCTION. THE PATIENT CONTINUED TO BE TREATED WITH ANTIBIOTICS. POST-PROCEDURE, THE PATIENT DEVELOPED UPPER EXTREMITY SWELLING WITH PAIN. UPPER EXTREMITY VENOUS DOPPLER REVEALED ACUTE DEEP VEIN THROMBOSIS (DVT) IN THE RIGHT SUBCLAVIAN, AXILLARY, AND PROXIMAL BRANCHIAL VEINS. NO ANTICOAGULATION WAS USED DUE TO ANEURYSM. A NEW SYSTEM WAS IMPLANTED APPROXIMATELY THREE WEEKS LATER. THE PATIENT IS A PARTICIPANT IN THE (B)(4) CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT CULTURES FROM THE LEFT SIDE GREW GRAM POSITIVE COCCOBACILLUS. A COMPUTERIZED TOMOGRAPHY (CT) ANGIOGRAPHY NOTED THAT THE ANEURYSM WAS SEEN ARISING FROM PROXIMAL INNOMINATE ARTERY AND A CT SCAN REVEALED OUT-POUCHING OF INNOMINATE ARTERY WITH SURROUNDING FAT AND FLUID. ONE WEEK AFTER THE NEW SYSTEM WAS IMPLANTED, THE PATIENT HAD AN AORTA TO DISTAL INNOMINATE ARTERY BIFURCATION BYPASS AND LIGATION OF INNOMINATE ARTERY REPAIR WITH AORTIC GRAFT WITH TISSUE CULTURE AND GREW NO ORGANISMS. THE PATIENT HAD NO FEVERS POST-OPERATION FOR THE REMAINDER OF THEIR HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872342 EVERA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DVBB1D4 00643169017948

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| R 6935M55 LEAD