BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 18117127 · Received November 11, 2023

    Report

    Report Number
    3006630150-2023-06955
    Event Type
    Injury
    Date Received
    November 11, 2023
    Date of Event
    October 6, 2023
    Report Date
    December 5, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC. UPN: M365SC14320. MODEL: SC-1432. SERIAL: (B)(6). BATCH: 213805.

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED ONE TO TWO WEEKS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7082401. PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43180, MODEL: SC-4318 , BATCH: 31230297.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD SOME SIGNS OF INFECTION AT THE LEAD INCISION SITE AND A DISCHARGE WAS NOTED. THE PHYSICIAN WANTED TO CHECK THE WOUND FOR ANY DEEPER INFECTION AND UPON DISSECTION, SUPERFICIAL INFECTION WAS NOTED AT THE VERTICAL INCISION WHERE THE LEADS WERE ANCHORED. THE IMPLANTED PRODUCT DID NOT CAUSE ANY ISSUES AND NO DEVICE WAS REPLACED OR ADDED. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS. UPON FOLLOW-UP, DISCHARGE WAS NOTED FROM THE VERTICAL INCISION AGAIN. ADDITIONAL INFORMATION WAS RECEIVED THAT MAGNETIC RESONANCE IMAGING (MRI) WAS TAKEN AND INFECTION WAS STILL PRESENT AT A SUPERFICIAL LEVEL. THE CAUSE OF INFECTION WAS NOT KNOWN. THE PHYSICIAN WAS MONITORING FOR THE INFECTION TO CLEAR UP, HOWEVER, PUS WAS NOTED COMING FROM THE IPG POCKET SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL DEVICE COMPONENTS WERE REMOVED AND KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD SOME SIGNS OF INFECTION AT THE LEAD INCISION SITE AND A DISCHARGE WAS NOTED. THE PHYSICIAN WANTED TO CHECK THE WOUND FOR ANY DEEPER INFECTION AND UPON DISSECTION, SUPERFICIAL INFECTION WAS NOTED AT THE VERTICAL INCISION WHERE THE LEADS WERE ANCHORED. THE IMPLANTED PRODUCT DID NOT CAUSE ANY ISSUES AND NO DEVICE WAS REPLACED OR ADDED. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS. UPON FOLLOW-UP, DISCHARGE WAS NOTED FROM THE VERTICAL INCISION AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192643 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7082383 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention