BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA XT

    MDR report key: 3860648 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-10534
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4): THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED A DAMAGED GROMMET. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER).

    Additional Manufacturer Narrative · 1

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

    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: 429688, PACING LEAD, IMPLANTED: (B)(6) 2014; 5076-45, PACING LEAD, IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM IMPLANT AND POST DEFIBRILLATION TESTING, 3 BRIEF MECHANICAL TYPE NOISE OVERSENSING VENTRICULAR EPISODES WERE OBSERVED. THE POCKET WAS RE-OPENED AND THE CONNECTIONS WERE VERIFIED. THE ICD WAS PLACED BACK IN THE POCKET AND ANOTHER EPISODE OF VENTRICULAR OVERSENSING WAS THEN OBSERVED. THE ICD AND RIGHT VENTRICULAR (RV) LEAD WERE REMOVED AND REPLACED. THE PATIENT DEVELOPED A HEMATOMA THAT WAS ATTRIBUTED TO GOING IN THE SECOND TIME TO REVISE THE SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339638 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTBA1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R 6947M62 TACHY LEAD