BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 3872217 · Received June 13, 2014

    Report

    Report Number
    1000165971-2014-00352
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    PP060027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY ANALYSIS OF THE RETURN DEVICE CONFIRMED IT OPERATED AS SPECIFIED.

    Description of Event or Problem · 1

    REPORTEDLY, A CONNECTION ISSUE OCCURED DURING THE IMPLANTATION OF THE SUBJECT ICD. THE SCREWDRIVER FAILED TO "CLICK" AND APPEARED TO JUST BE SPINNING WHILE SCREWING THE (SVC)DF-1 SETCREW. SAME BEHAVIOR WITH A SECOND SCREWDRIVER. IT IS IMPORTANT TO HIGHLIGHT THAT BOTH SCREWDRIVERS FUNCTIONED AS EXPECTED ON THE OTHER 2 SETSCREWS ON THE DEVICE. WHEN TUGGING ON THE (SVC)DF-1 PORTION OF THE LEAD CONNECTED TO THE HEADER, IT APPEARED TO BE SNUG AS IT WOULD NOT DISENGAGE HOWEVER THE PHYSICIAN PREFERED NOT TO IMPLANT THE DEVICE AND IT WILL BE RETURNED FOR ANALYSIS. ANOTHER DEVICE WAS SUCCESSFULLY IMPLANTED.

    Description of Event or Problem · 1

    REPORTEDLY, A CONNECTION ISSUE OCCURED DURING THE IMPLANTATION OF THE SUBJECT ICD. THE SCREWDRIVER FAILED TO "CLICK" AND APPEARED TO JUST BE SPINNING WHILE SCREWING THE (SVC)DF-1 SETCREW. SAME BEHAVIOR WITH A SECOND SCREWDRIVER. IT IS IMPORTANT TO HIGHLIGHT THAT BOTH SCREWDRIVERS FUNCTIONED AS EXPECTED ON THE OTHER 2 SETSCREWS ON THE DEVICE. WHEN TUGGING ON THE (SVC) DF-1 PORTION OF THE LEAD CONNECTED TO THE HEADER, IT APPEARED TO BE SNUG AS IT WOULD NOT DISENGAGE HOWEVER THE PHYSICIAN PREFERRED NOT TO IMPLANT THE DEVICE AND IT WILL BE RETURNED FOR ANALYSIS. ANOTHER DEVICE WAS SUCCESSFULLY IMPLANTED.

    Description of Event or Problem · 1

    REPORTEDLY, A CONNECTION ISSUE OCCURED DURING THE IMPLANTATION OF THE SUBJECT ICD. THE SCREWDRIVER FAILED TO "CLICK" AND APPEARED TO JUST BE SPINNING WHILE SCREWING THE (SVC)DF-1 SETSCREW. SAME BEHAVIOR WITH A SECOND SCREWDRIVER. IT IS IMPORTANT TO HIGHLIGHT THAT BOTH SCREWDRIVERS FUNCTIONED AS EXPECTED ON THE OTHER 2 SETSCREWS ON THE DEVICE. WHEN TUGGING ON THE (SVC)DF-1 PORTION OF THE LEAD CONNECTED TO THE HEADER, IT APPEARED TO BE SNUG AS IT WOULD NOT DISENGAGE HOWEVER THE PHYSICIAN PREFERRED NOT TO IMPLANT THE DEVICE AND IT WILL BE RETURNED FOR ANALYSIS. ANOTHER DEVICE WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349769 PARADYM DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF VR 9250 2726

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization