BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATIO

    MDR report key: 3315833 · Received August 23, 2013

    Report

    Report Number
    9610579-2013-00068
    Event Type
    Injury
    Date Received
    August 23, 2013
    Date of Event
    June 6, 2013
    Report Date
    August 5, 2013
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P9800549
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NOISE ON V LEAD CAUSING OVERSENSING WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416173 OVATIO MRM SORIN CRM OVATIO DR 6550 S070206

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention