BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTO

    MDR report key: 2915003 · Received January 10, 2013

    Report

    Report Number
    9610579-2013-00001
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 18, 2012
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, DURING NORMAL DEVICE REPLACEMENT (ELECTIVE REPLACEMENT INDICATOR REACHED), THE PHYSICIAN UNSCREWED THE CONNECTOR SETSCREWS; DURING THIS PROCEDURE, TWO SILICON SETSCREW COVERS GOT DETACHED FROM DEVICE HEADER. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15260 ALTO MRM SORIN CRM ALTO VR 625 S051017

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention