BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA XT

    MDR report key: 3862429 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11074
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    December 19, 2013
    Report Date
    March 10, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE RETURNED DEVICE INDICATED A LOOSE/DETACHED SET SCREW. CONCOMITANT PRODUCT: 419488, IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REPLACED DUE TO MALFUNCTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338161 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBA1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R 5592-53 IMPLANTABLE PACING LEAD