BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA XT

    MDR report key: 3861567 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11181
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    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. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, UPON ATTACHING THE RV (RIGHT VENTRICULAR) LEAD TO THE HEADER, NOISE AND PACING INHIBITION WERE NOTED. THE LEAD WAS DISCONNECTED AND RETESTED VIA THE ANALYZER, WITH MEASUREMENTS FOUND TO BE WITHIN NORMAL LIMITS. UPON REATTACHING THE LEAD, NOISE AND PACING INHIBITION WERE AGAIN NOTED. THE SETSCREW WAS BACKED OUT AND THEN RETORQUED, BUT WITHOUT IMPROVEMENT. THE LEAD PIN WAS VISIBLY NOTED TO BE FULLY INSERTED INTO THE HEADER. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343186 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTBA1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR 6947M62 LEAD