BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2972348 · Received February 15, 2013

    Report

    Report Number
    1000165971-2013-00077
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    November 28, 2012
    Report Date
    January 31, 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
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON 02/15/2013, 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 VISIT ON (B)(6) 2012, A NON-SUSTAINED NOISE EPISODE, DATED (B)(6) 2012, WAS STORED WITHIN THE MEMORY OF THE ICD. REPORTEDLY, R WAVE TREND AND IMPEDANCE WERE CONSTANT AND NORMAL. THE PATIENT ALSO REPORTED A RECENT PURCHASE OF A PORTABLE INDUCTION KITCHEN, SO THE PHYSICIAN SUSPECTS EXTERNAL INTERFERENCE. TESTING RELATED TO HIS EQUIPMENT SUGGESTED EMI THAT INHIBITS TELEMETRY, BUT NOISE COULD NOT BE CONFIRMED SINCE TEMPORARY PROGRAMMING IS INTERRUPTED EACH TIE THE KITCHEN IS TURNED-ON. ALSO, NOISE EPISODES WERE NOT PRESENT WITHIN THE MEMORY OF THE ICD. THE PATIENT ALSO REPORTED FEELING A SLIGHT PASSAGE OF CURRENT WHEN TOUCHING A COW FENCE UNDER A HIGH VOLTAGE LINE; ICD MEMORY DATE ALSO RECORDED OVERSENSING EPISODES ON 10/12/2011 AND 10/15/2011 DUE TO THIS. THE PHYSICIAN INDICATED THAT THIS CURRENT WAS ACTUALLY INDUCED BY THE FENCE DUE TO THE HIGHT VOLTAGE LINE ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69408 PARADYM MRM SORIN C.R.M., S.R.L. PARADYM VR 8250 2400

    Patients

    Seq Age Sex Outcome Treatment
    1