BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2972338 · Received February 15, 2013

    Report

    Report Number
    1000165971-2013-00064
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 7, 2013
    Report Date
    February 1, 2013
    Manufacturer
    SORIN C.R.M., S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    UPON ICD INTERROGATION DURING A REGULAR FOLLOW-UP, IT WAS NOTICED THAT SEVERAL ARRHYTHMIA EPISODES WERE CLASSIFIED AS VENTRICULAR FIBRILLATION BY THE IMPLANT. HOWEVER, THE REVIEW OF THESE EPISODES DID NOT REVEAL ANY VF, AND PHYSICIAN SUSPECTED THE PRESENCE OF EXTERNAL NOISE OVERSENSING. AN EXPLANATION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69517 PARADYM MRM SORIN C.R.M., S.R.L. PARADYM DR 8550 2391

    Patients

    Seq Age Sex Outcome Treatment
    1