BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 10390970 · Received August 11, 2020

    Report

    Report Number
    3006630150-2020-03351
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    July 21, 2020
    Report Date
    August 11, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R: UPN: (B)(4), MODEL: SC-1132, SERIAL: (B)(4), BATCH: 19751337. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 5162828. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 17354107/17489734.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE LEAD SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL DEVICE COMPONENTS WERE EXPLANTED AND WERE NOT RETURNED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856890 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 5162117 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention