BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATIO CRT

    MDR report key: 2241823 · Received September 9, 2011

    Report

    Report Number
    2182863-2011-00083
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    June 24, 2011
    Report Date
    August 15, 2011
    Manufacturer
    SORIN CRM S.A.S.
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2011. THE ANALYSIS ON THIS DEVICE IS PENDING.

    Additional Manufacturer Narrative · 1

    (B)(4), 2011.THE ANALYSIS ON THIS DEVICE IS PENDING. (B)(4).

    Description of Event or Problem · 1

    AFTER 2+ YEARS OF IMPLANTATION, THIS ICD WAS EXPLANTED BECAUSE THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS DUE TO NOISE. IN ADDITION, THERE WAS OVERSENSING. A NEW PARADYM WAS IMPLANTED.

    Description of Event or Problem · 1

    AFTER 2+ YEARS OF IMPLANTATION, THIS ICD WAS EXPLANTED BECAUSE THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS DUE TO NOISE. IN ADDITION, THERE WAS OVERSENSING. A NEW PARADYM WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO CRT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MRM SORIN CRM S.A.S. 6750

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR