BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 14282032 · Received May 4, 2022

    Report

    Report Number
    3006630150-2022-02003
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    April 7, 2022
    Report Date
    May 3, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789581
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352500. MODEL: SC-2352-50. SERIAL: (B)(4). BATCH: 7073564. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(4). BATCH: 7072362. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352500. MODEL: SC-2352-50. SERIAL: (B)(4). BATCH: 7072674.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING ONGOING REDNESS AROUND THE INITIAL LEAD ENTRY SITE THAT WASN'T HEALING. CULTURES TAKEN REVEALED A STAPH INFECTION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE LEADS WERE EXPLANTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND EXPECTED TO FULLY RECOVER. BOSTON SCIENTIFIC MADE GOOD FAITH EFFORT ATTEMPTS TO RETRIEVE THE EXPLANTED DEVICES, BUT THE LEADS WERE DISPOSED OF AT THE FACILITY AND WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789389 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-70 7070759 08714729789581

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention