BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 1880176 · Received October 22, 2010

    Report

    Report Number
    2182863-2010-00100
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2010. THE DEVICE REMAINS IMPLANTED. A RE-INTERVENTION WAS PERFORMED SUCCESSFULLY. A RESPONSE FROM THE MANUFACTURER IS PENDING. (B)(4) 2011. SINCE THE DEVICE REMAINS IMPLANTED, THE MANUFACTURING RECORDS WERE REVIEWED. AS PART OF THE MANUFACTURING PROCESS, AN X-RAY IMAGE IS TAKEN OF THE DEVICE AT THE FINAL STAGE AND NO ABNORMALITIES WERE IDENTIFIED. IT WAS REPORTED THAT THE PHYSICIAN WAS CONCERNED ABOUT WHY A BLUE WRENCH IS NOT PROVIDED FOR RE-INTERVENTIONS ON SORIN DEVICES IN THE US. THE REPORT FROM THE MANUFACTURER NOTES THAT A SCREWDRIVER IS AVAILABLE IN THE USA AS AN ACCESSORY FOR POTENTIAL RE-INTERVENTIONS ON PARADIGM DEVICES. SINCE THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS, NO FURTHER COMMENT CAN BE MADE. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE REMAINS IMPLANTED. A RE-INTERVENTION WAS PERFORMED SUCCESSFULLY. A RESPONSE FROM THE MANUFACTURER IS PENDING. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    A RE-INTERVENTION WAS PERFORMED 4 WEEKS AFTER IMPLANTATION DUE TO HIGH RV AND LV LEAD IMPEDANCES, >3000 OHMS. THE POCKET WAS OPENED AND A TUG TEST WAS PERFORMED, THE LEAD PULLED OUT OF THE HEADER. THEREFORE, THE LEADS WERE RE-INSERTED AND TIGHTENED DOWN SUCCESSFULLY WITH A BLUE HANDLED WRENCH THAT HAS MORE TORQUE.

    Description of Event or Problem · 1

    A RE-INTERVENTION WAS PERFORMED 4 WEEKS AFTER IMPLANTATION DUE TO HIGH RV AND LV LEAD IMPEDANCES, >3000 OHMS. THE POCKET WAS OPENED AND A TUG TEST WAS PERFORMED, THE LEAD PULLED OUT OF THE HEADER. THEREFORE, THE LEADS WERE RE-INSERTED AND TIGHTENED DOWN SUCCESSFULLY WITH A BLUE HANDLED WRENCH THAT HAS MORE TORQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK SORIN BIOMEDICA CRM S.R.L. 8750

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R