BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA QUAD XT

    MDR report key: 3284697 · Received August 14, 2013

    Report

    Report Number
    3004209178-2013-13236
    Event Type
    Injury
    Date Received
    August 14, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 407645 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2013; 429878 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2013; 694 7M55 IMPLANTABLE TACHYCARDIA LEAD, IMPLANTED: (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFECTION AT THE POCKET SITE. THE PATIENT WAS TREATED WITH ANTIBIOTICS. ALL EVIDENCE SUGGESTS THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR REMAINS IMPLANTED AND IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390926 VIVA QUAD XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBX1QQ

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Hospitalization| R