BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA XT

    MDR report key: 3861217 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11245
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 6, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND. ANALYST COMMENTED, NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 5076-52, LEAD, IMPLANTED: (B)(6) 2009; 694765, LEAD, IMPLANTED: (B)(6) 2009. (B)(4).

    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 WAS HOSPITALIZED DUE TO THE IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD OUT OF RANGE WHICH TRIGGERED A LEAD WARNING. RV AND SVC COILS IMPEDANCES HAVE BEEN ELEVATED AND VARIABLE. INVASIVE ANALYSIS WAS PERFORMED ALONG WITH PROVOCATIVE ISOMETRIC MOVEMENTS. POCKET MANIPULATION REVEALED HIGH AND VARIABLE IMPEDANCES. AN RV COIL CONNECTION ISSUE WAS DISCUSSED. SUBSEQUENT TROUBLESHOOTING AND ANALYSIS REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RV HV CONNECTOR WAS LOOSE. THE POCKET WAS OPENED; THE RV HV CONNECTOR WAS REMOVED AND REATTACHED ALONG WITH THE SET SCREW TIGHTENED. CONNECTION AND NORMAL RV LEAD FUNCTION WAS CONFIRMED. THE LEAD AND ICD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340733 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBA1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R 419678 LEAD