BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 14639372 · Received June 8, 2022

    Report

    Report Number
    3006630150-2022-02763
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    May 5, 2022
    Report Date
    June 8, 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

    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-LINEAR LEADS, UPN: M365SC2366700 MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 2000009289/2000009290/2000009287/7072524/7072525/7072704.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND TIGHTNESS AT THE UPPER NECK LEAD INCISION SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS CUT AND REMAINED PLUGGED INTO THE PORT A OF THE NEW IPG WHICH RELOCATED AT THE RIGHT ABDOMEN. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631980 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 16835873 08714729789567

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention