BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM 2

    MDR report key: 4426950 · Received January 16, 2015

    Report

    Report Number
    1000165971-2015-00023
    Event Type
    Malfunction
    Date Received
    January 16, 2015
    Date of Event
    December 4, 2014
    Report Date
    December 17, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE U.S.; HOWEVER, IT IS SIMILAR TO PARADYM MODELS APPROVED UNDER P980049.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT DURING THE IMPLANT PROCEDURE RELATIVE TO THE SUBJECT ICD, THE ASSOCIATED DF-1 INSULATION PLUG COULD NOT BE FULLY INSERTED INTO THE CHANNEL AND THUS NOT CONNECTED. THE PHYSICIAN TRIED SEVERAL TIMES WITH FINGERS AND WITH CLAMPS WITHOUT SUCCESS. THE PLUG FROM ANOTHER ICD WAS UTILIZED INSTEAD. FURTHERMORE, IT WAS REPORTED THAT THE PHYSICIAN INCURRED DIFFICULTIES WHEN INSERTING THE SCREWDRIVER IN THE SOCKET OF THE IS-1 CHANNEL. DIFFERENT SCREWDRIVERS WERE UTILIZED AND IT WAS NOT PROPERLY INSERTED AND DID NOT PROPERLY TIGHTEN THE SET-SCREW. FINALLY, THE SCREWDRIVER WAS INSERTED CORRECTLY AND THE SCREW TIGHTENED. THE SUBJECT ICD WAS SUBSEQUENTLY IMPLANTED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT DURING THE IMPLANT PROCEDURE RELATIVE TO THE SUBJECT ICD, THE ASSOCIATED DF-1 INSULATION PLUG COULD NOT BE FULLY INSERTED INTO THE CHANNEL AND THUS NOT CONNECTED. THE PHYSICIAN TRIED SEVERAL TIMES WITH FINGERS AND WITH CLAMPS WITHOUT SUCCESS. THE PLUG FROM ANOTHER ICD WAS UTILIZED INSTEAD. FURTHERMORE, IT WAS REPORTED THAT THE PHYSICIAN INCURRED DIFFICULTIES WHEN INSERTING THE SCREWDRIVER IN THE SOCKET OF THE IS-1 CHANNEL. DIFFERENT SCREWDRIVERS WERE UTILIZED AND IT WAS NOT PROPERLY INSERTED AND DID NOT PROPERLY TIGHTEN THE SET-SCREW. FINALLY, THE SCREWDRIVER WAS INSERTED CORRECTLY AND THE SCREW TIGHTENED. THE SUBJECT ICD WAS SUBSEQUENTLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41454 PARADYM 2 MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM 2 VR 8252 2816

    Patients

    Seq Age Sex Outcome Treatment
    1