BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATIO

    MDR report key: 1895387 · Received November 4, 2010

    Report

    Report Number
    9610579-2010-00614
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 23, 2010
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2010. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE ICD INVOLVED IN THIS MDR WAS IMPLANTED ON (B)(6) 2009. THE REPORTED EVENT OCCURRED ON (B)(6) 2010: REPORTEDLY, THE PT RECEIVED 6 INAPPROPRIATE SHOCKS UPON A SINUS TACHYCARDIA EPISODE (THE PT WAS EXERCISING / PLAYING BASKET BALL). THE PT EXPLAINED THAT HE FELT THE SHOCKS (HE FELL ON THE GROUND BECAUSE OF THE SHOCKS). THE ICD WAS INTERROGATED DURING A F/U PERFORMED ON (B)(6) 2010. INTERROGATION SHOWED A WARNING MESSAGE: "LOW SHOCK IMPEDANCE : DEFIBRILLATION SYSTEM INEFFECTIVE". CONTINUITY MEASUREMENTS PERFORMED ON THAT DAY DID NOT SHOW ANY ANOMALY. REPORTEDLY, PT RECORDS SHOW HUNDREDS OF ADEQUATELY DIAGNOSED SINUS TACHYCARDIA EPISODES (EXCEPT THIS ONE LEADING TO INAPPROPRIATE SHOCKS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO MRM SORIN CRM OVATIO VR 6250 S090327

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention