BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 3062819 · Received April 12, 2013

    Report

    Report Number
    1000165971-2013-00208
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 4, 2013
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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

    REPORTEDLY, DURING AN ATTEMPT TO IMPLANT THE ICD INVOLVED IN THIS MDR REPORT, THE (RV) IS-1 LEAD TIP WAS FIXATED IN THE HEADER BUT NO TORQUE-SCREWDRIVER RATTLE COULD BE HEARD WHEN SCREWING. THE PHYSICIAN HAD NO CONFIDENCE IN THE INTEGRITY OF THE SYSTEM AND WANTED TO REMOVE THE LEAD FROM THE DEVICE. THE SETSCREW WAS "UNSCREWED" BUT IT WAS VERY DIFFICULT (NO GRIP FROM SCREWDRIVER ON THE SETSCREW). IN A SECOND ATTEMPT WITH A NEW SCREWDRIVER, RV DF-1 SETSCREW WAS UNSCREWED BUT (RV) IS-1 SETSCREW WAS UNSCREWED WITH THE SAME DIFFICULTIES. THE PHYSICIAN REPLACED THE SUBJECT DEVICE WHICH WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157302 PARADYM MRM SORIN CRM S.R.L. PARADYM RF VR 9250 2627

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention