BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 18179223 · Received November 20, 2023

    Report

    Report Number
    3006630150-2023-07221
    Event Type
    Injury
    Date Received
    November 20, 2023
    Date of Event
    October 27, 2023
    Report Date
    February 14, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: 7079253. PRODUCT FAMILY: SCS-IPG-PC. UPN: M365SC14320. MODEL: SC-1432. SERIAL: (B)(6). BATCH: 212155. PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC2317700. MODEL: SC-4318. SERIAL: N/A. BATCH: 30959009. PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC2317700. MODEL: SC-4318. SERIAL: N/A. BATCH: 30959009.

    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: 7079253.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED DISCHARGE AND REDNESS AT THE LEAD INSERTION SITE RELATED TO THE RECENT SCS IMPLANT PROCEDURE. THEREFORE, THE PATIENT UNDERWENT A DEBRIDEMENT PROCEDURE AND WAS PLACED ON ORAL ANTIBIOTICS. CULTURE RESULTS CONFIRMED THE PRESENCE OF A STAPHYLOCOCCAL INFECTION. THE PATIENT HAS FULLY RECOVERED POSTOPERATIVELY. THE SCS DEVICE REMAINS IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT EXPERIENCED POOR WOUND HEALING AS A RESULT OF THE INFECTION THAT HAD OCCURRED. WHILE CHANGING OUT THEIR WOUND DRESSING, THE PATIENT ACCIDENTALLY PULLED THE LEAD AND CLIK ANCHOR OUT OF THEIR SKIN WHILE STILL ATTACHED TO THE IMPLANTABLE PULSE GENERATOR (IPG). THEREFORE, THE PATIENT WAS HOSPITALIZED AND UNDERWENT AN EXPLANT PROCEDURE DURING WHICH THE LEADS AND IPG WERE REMOVED. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED DISCHARGE AND REDNESS AT THE LEAD INSERTION SITE RELATED TO THE RECENT SCS IMPLANT PROCEDURE. THEREFORE, THE PATIENT UNDERWENT A DEBRIDEMENT PROCEDURE AND WAS PLACED ON ORAL ANTIBIOTICS. CULTURE RESULTS CONFIRMED THE PRESENCE OF A STAPHYLOCOCCAL INFECTION. THE PATIENT HAS FULLY RECOVERED POSTOPERATIVELY. THE SCS DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2046646 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7070787 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown Required Intervention