BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA QUAD S

    MDR report key: 6005088 · Received October 6, 2016

    Report

    Report Number
    3004209178-2016-20625
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    July 13, 2016
    Report Date
    July 13, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED ANALYZED BUT NO ISSUE IDENTIFIED THAT REQUIRED FULL ANALYSIS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE SYSTEM WAS EXPLANTED DUE TO SEPSIS AND VEGETATION ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658293 VIVA QUAD S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTBB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R 407645 LEAD, (B)(4) LEAD