BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 17718330 · Received September 11, 2023

    Report

    Report Number
    3006630150-2023-05460
    Event Type
    Malfunction
    Date Received
    September 11, 2023
    Date of Event
    August 18, 2023
    Report Date
    November 29, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SC-2317-70 (B)(6). THE RETURNED DEVICE WAS ANALYZED, AND VISUAL INSPECTION REVEALED THAT THE TOP FIVE ELECTRODES ARE SEPARATED FROM THE DISTAL END. ELECTRODES 1-5 WERE NOT RETURNED. THE CABLES WERE EXPOSED AT THE DAMAGED PORTION OF THE LEAD. IT APPEARS THAT THE LEAD WAS STRONGLY PULLED DURING THE ATTEMPTED REMOVAL OF THE CLIK X ANCHOR. THE LEAD AND CLIK X ANCHOR MOST LIKELY WERE NOT WELL LUBRICATED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE LEAD BECAME SHREDDED WHEN TRYING TO PRELOAD, PASS OR ADVANCE THE CLICK X ANCHOR WAS CONFIRMED. THE PROBABLE CAUSE FOR THE LEAD DAMAGE IS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCK D4.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7082260.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE DISTAL END OF THE LEAD BECAME SHREDDED WHEN TRYING TO PRELOAD, PASS OR ADVANCE THE CLICK X ANCHOR AND IT WAS UNKNOWN IF THE SAID LEAD WAS IMPLANTED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE DISTAL END OF THE LEAD BECAME SHREDDED WHEN TRYING TO PRELOAD, PASS OR ADVANCE THE CLICK X ANCHOR AND IT WAS UNKNOWN IF THE SAID LEAD WAS IMPLANTED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE DISTAL END OF THE LEAD BECAME SHREDDED WHEN TRYING TO PRELOAD, PASS OR ADVANCE THE CLICK X ANCHOR AND IT WAS UNKNOWN IF THE SAID LEAD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145756 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7081699 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other