BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET LEAD SMALL-S, 86 CM

    MDR report key: 8641880 · Received May 24, 2019

    Report

    Report Number
    2017865-2019-08624
    Event Type
    Injury
    Date Received
    May 24, 2019
    Date of Event
    May 10, 2019
    Report Date
    June 11, 2019
    Manufacturer
    ABBOTT
    Product Code
    NIK
    UDI-DI
    05414734510158
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF INFECTION WAS UNCONFIRMED. THE LEAD WAS RETURNED WITH NO MALFUNCTION ASSOCIATED WITH IT. VISUAL EXAMINATION REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2019-04076 AND 2938836-2019-04074. THE PATIENT PRESENTED IN CLINIC DUE AN EROSION OF THE DEVICE POCKET. THE DEVICE WAS EXPOSED DUE TO A POCKET DECUBITUS. THE SYSTEM WAS EXPLANTED AND A NEW SYSTEM IMPLANTATION IS EXPECTED. THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433540 QUARTET LEAD SMALL-S, 86 CM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ABBOTT 1456Q/86 A000071823 05414734510158

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R DURATA STS OPTIM ACTIVE FIXATION| QUADRA ASSURA MP ICD