BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 17683452 · Received September 5, 2023

    Report

    Report Number
    3006630150-2023-05296
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    August 9, 2023
    Report Date
    September 18, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO INITIAL MDR IN BLOCK B5 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. LOT: 31230299. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC231700. MODEL: SC-2317-70. SERIAL: (B)(6). LOT: 7081981. PRODUCT FAMILY: SCS-IPG-R-MRI. UPN: M365SC12320. MODEL: SC-1232. SERIAL: (B)(6). LOT: 569193.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. LOT: 31230299. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC231700. MODEL: SC-2317-70. SERIAL: (B)(6) . LOT: 7081981 . PRODUCT FAMILY: SCS-IPG-R-MRI. UPN: M365SC12320. MODEL: SC-1232. SERIAL: (B)(6). LOT: 569193.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) PROCEDURE IN WHICH TWO SCS LEADS WERE IMPLANTED. THE FOLLOWING DAY, AFTER THE LEAD WAS FIXED WITH A CLIKX ANCHOR, THE ELECTRODE AT THE IMPLANTABLE PULSE GENERATOR (IPG) CONNECTION WAS PROTECTED WITH A LEAD EXTENSION AND TEMPORARILY IMPLANTED INTO THE BODY. AFTER OPENING THE LEAD INSERTION SITE, IT WAS FOUND THAT THE ANCHOR WHERE THE RIGHT LEAD (LOT: 7081984) WAS PLACED HAD MOVED FROM THE POSITION WHERE IT WAS FIXED THE DAY BEFORE AND HAD FALLEN INTO A LOOPED POSITION. THE PHYSICIAN DETERMINED THAT THE LEAD SHOULD BE SECURED WITH THREAD TO PREVENT IT FROM FALLING FURTHER, AND IPG IMPLANTATION WAS PERFORMED. THE POSTOPERATIVE X-RAY SHOWED THAT THE RIGHT LEAD, WHOSE ANCHOR HAD BEEN SEPARATED, HAD DROPPED BY APPROXIMATELY 2 VERTEBRAE, THE TIP WAS LOCATED AT THE HEIGHT OF THORACIC-12, AND THE HEIGHT OF THE LEFT LEAD OVERLAPPED BY FIVE ELECTRODES. IT WAS NOTED THAT DURING LEAD IMPLANTATION, THE LEFT AND RIGHT LEADS WERE IMPLANTED AT THE SAME HEIGHT WITH THE TIP AT THORACIC-10. THE LEFT LEAD HAD REMAINED UNCHANGED SINCE BEING IMPLANTED. IN THE POSTOPERATIVE ADJUSTMENT SHOWED THAT THE ELECTRODE NEAR THORACIC-12 WAS THE CENTRAL POINT OF STIMULATION, AND SINCE THE PAIN SITE AND PARESTHESIA OVERLAPPED, IT WAS DECIDED THAT THE SITUATION WOULD BE MONITORED WHILE USING THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A DEEP BRAIN STIMULATION (DBS) PROCEDURE IN WHICH TWO DBS LEADS WERE IMPLANTED. THE FOLLOWING DAY, AFTER THE LEAD WAS FIXED WITH A CLIKX ANCHOR, THE ELECTRODE AT THE IMPLANTABLE PULSE GENERATOR (IPG) CONNECTION WAS PROTECTED WITH A LEAD EXTENSION AND TEMPORARILY IMPLANTED INTO THE BODY. AFTER OPENING THE LEAD INSERTION SITE, IT WAS FOUND THAT THE ANCHOR WHERE THE RIGHT LEAD (LOT: 7081984) WAS PLACED HAD MOVED FROM THE POSITION WHERE IT WAS FIXED THE DAY BEFORE AND HAD FALLEN INTO A LOOPED POSITION. THE PHYSICIAN DETERMINED THAT THE LEAD SHOULD BE SECURED WITH THREAD TO PREVENT IT FROM FALLING FURTHER, AND IPG IMPLANTATION WAS PERFORMED. THE POSTOPERATIVE X-RAY SHOWED THAT THE RIGHT LEAD, WHOSE ANCHOR HAD BEEN SEPARATED, HAD DROPPED BY APPROXIMATELY 2 VERTEBRAE, THE TIP WAS LOCATED AT THE HEIGHT OF THORACIC-12, AND THE HEIGHT OF THE LEFT LEAD OVERLAPPED BY FIVE ELECTRODES. IT WAS NOTED THAT DURING LEAD IMPLANTATION, THE LEFT AND RIGHT LEADS WERE IMPLANTED AT THE SAME HEIGHT WITH THE TIP AT THORACIC-10. THE LEFT LEAD HAD REMAINED UNCHANGED SINCE BEING IMPLANTED. IN THE POSTOPERATIVE ADJUSTMENT SHOWED THAT THE ELECTRODE NEAR THORACIC-12 WAS THE CENTRAL POINT OF STIMULATION, AND SINCE THE PAIN SITE AND PARESTHESIA OVERLAPPED, IT WAS DECIDED THAT THE SITUATION WOULD BE MONITORED WHILE USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006412 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7081984 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention