BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 11984552 · Received June 11, 2021

    Report

    Report Number
    3006630150-2021-02855
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    May 18, 2021
    Report Date
    September 28, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SMALL BUMP FROM THE LEAD OF THE PATIENTS LEFT EAR WAS IRRITATED BY THE GLASSES. IT WAS ALSO NOTED THAT THE LEAD WAS VERY CLOSE TO THE SURFACE OF THE SKIN. THE PHYSICIAN TUCKED THE LEAD UNDERNEATH THE TISSUE AND PERFORMED A WOUND CLOSURE. THE PATIENT WAS PLACED ON INTRAVENOUS ANTIBIOTICS AND WAS DOING WELL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS LEAD BEHIND THE EAR POKED THROUGH THE SKIN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: (B)(4). MODEL: SC-2218-50 SERIAL: (B)(4). BATCH: 7070457 PRODUCT FAMILY: SCS-LINEAR LEADS UPN: (B)(4). MODEL: SC-2352-50 SERIAL: (B)(4). BATCH: 5167251

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL BUMP FROM THE LEAD OF THE PATIENTS LEFT EAR WAS IRRITATED BY THE GLASSES. IT WAS ALSO NOTED THAT THE LEAD WAS VERY CLOSE TO THE SURFACE OF THE SKIN. THE PHYSICIAN TUCKED THE LEAD UNDERNEATH THE TISSUE AND PERFORMED A WOUND CLOSURE. THE PATIENT WAS DOING WELL AND WAS PLACED ON INTRAVENOUS ANTIBIOTICS TO PREVENT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879557 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 5154894 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention