BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 2914956 · Received January 10, 2013

    Report

    Report Number
    1000165971-2013-00007
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 20, 2012
    Manufacturer
    SORIN C.R.M., S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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

    REPORTEDLY, THE ICD INVOLVED IN THIS MDR REPORT WAS IMPLANTED AFTER THE LEAD WAS CHECKED. THE POCKET WAS CLOSED AND THE PROGRAMMER SHOWED HIGH IMPEDANCES (>3000 OHMS) EVEN AFTER SEVERAL ATTEMPTS, SO IT WAS DECIDED TO OPEN THE POCKET. IT WAS FOUND OUT THAT THERE WAS A MISTAKE IN THE CONNECTIONS: THE PACING/SENSING CONNECTOR IN VENTRICLE (IS-1 CONNECTION) WAS CONNECTED WHERE THE SVC COIL SHOULD BE CONNECTED (DF-1 CONNECTION) AND VICE VERSA. THE RV COIL (DF-1 CONNECTION) WAS PROPERLY CONNECTED. AFTER CORRECT REPOSITIONING OF THE CONNECTION PINS, DURING THE INTERROGATION THE MEASURES OF THE COIL IMPEDANCES WERE OK BUT THE PACING IMPEDANCE REMAINED TOO HIGH (>3000 OHMS). THEN THE ICD WAS DISCONNECTED AGAIN AND THE MEASUREMENTS OF THE LEAD WERE TAKEN WITH PACE SYSTEM ANALYZER AGAIN AND WERE NORMAL. THE ICD WAS CONNECTED AGAIN BUT THE HIGH PACING IMPEDANCE REMAINED. UNDERSTANDING THAT THE LEAD WAS NOT THE PROBLEM, THE ICD WAS REPLACED WITHOUT SHOWING ANY ANOMALY. THE SUBJECT ICD WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13428 PARADYM MRM SORIN C.R.M., S.R.L. PARADYM RF VR 9250 2609

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention