BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 2992312 · Received March 1, 2013

    Report

    Report Number
    1000165971-2013-00117
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 21, 2013
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE: (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

    DURING A FOLLOW-UP RELATIVE TO THE SUBJECT LEAD, NOISE OVERSENSING WAS CONFIRMED IN THE VENTRICULAR CHANNEL IN A RECORDED EPISODE. THE ASSOCIATED ICD IS AN OVATIO DR 6550; SN: (B)(4). THE DATE OF THIS EPISODE OF OVERSENSING WAS (B)(6) 2012 (01:36). ASSOCIATED LEAD MEASUREMENTS WERE NORMAL DURING THE CHECK (THRESHOLD 0.5V/0.35MS, IMPEDANCE 587OHMS, R WAVE AMPLITUDE 16.8MV), INCLUDING COIL CONTINUITY. ALSO, NO ANOMALY WAS OBSERVED BY X-RAY EXAMINATION. THE SUBJECT LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89327 ISOLINE MRM SORIN CRM ISOLINE 2CR6 2408

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention