BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA QUAD S

    MDR report key: 3990538 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14433
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 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
    MN, US
    Reporter Occupation
    OTHER

    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. CONCOMITANT MEDICAL PRODUCTS: 4968-60, LEAD, IMPLANTED: (B)(6) 2014; 6725, ADAPTOR, IMPLANTED: (B)(6) 2014; 1888TC-52, ST. JUDE LEAD, IMPLANTED: (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH EXTRANEOUS STIMULATION. THE LEFT VENTRICULAR (LV) LEAD WAS NOT CAPTURING AT MAXIMUM OUTPUTS AND HAD NO CAPTURE WITH ANY VECTOR CONFIGURATION. THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM FOR POSSIBLE LEAD REPOSITIONING. WHEN THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REMOVED FROM THE POCKET A TUG TEST WAS REQUESTED. WHEN THE TUG TEST WAS PERFORMED, THE LEAD PULLED OUT OF THE HEADER. THE LEAD WAS REPLACED INTO THE HEADER, THE SET SCREW WAS TIGHTENED, AND A TUG TEST WAS PERFORMED AND SHOWED GOOD CONTACT. TESTING THROUGH THE DEVICE SHOWED GOOD IMPEDANCE AND THRESHOLD MEASUREMENTS. THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468273 VIVA QUAD S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R 6935M62, LEAD