BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 16048583 · Received December 26, 2022

    Report

    Report Number
    3006630150-2022-07292
    Event Type
    Injury
    Date Received
    December 26, 2022
    Date of Event
    December 12, 2022
    Report Date
    December 26, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789567
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 7073593.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS SWELLING AT THE LEAD INCISION SITE AND INFECTION WAS SUSPECTED. IT WAS NOTED THAT PATIENTS ISSUE WAS NOT PROCEDURE RELATED, HOWEVER, THE CAUSE WAS UNKNOWN. THE PATIENT HAD A LEAD PULL AND WAS GIVEN ANTIBIOTICS. THE LEAD WAS NOT RETURNED AS IT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2811928 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 7073592 08714729789567

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention