BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA XT

    MDR report key: 3991277 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14307
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. THE SET SCREW WAS LOOSE/DETACHED AND WAS DAMAGED.

    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 AND ANALYZED. ANALYSIS REVEALED THE DEVICE HAD A LOOSE/DETACHED AS WELL AS DAMAGED SET SCREW. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SYSTEM UPGRADE PROCEDURE, THE NEWLY IMPLANTED RIGHT VENTRICULAR (RV) LEAD SHOWED INTERMITTENT LOSS OF CAPTURE. THE PHYSICIAN WANTED TO TEST THE LEAD ON THE ANALYZER, HOWEVER, THEY EXPERIENCED MUCH DIFFICULTY WHEN LOOSENING THE RV CHANNEL SET SCREW ON THE NEW CARDIAC RESYNCHRONIZATION THERAPY - DEFIBRILLATOR (CRT-D). THE ANALYZER SHOWED NORMAL READINGS SO THE CRT-D DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472800 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTBA1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR (B)(4) LEAD