BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR 3-4

    MDR report key: 18968429 · Received March 25, 2024

    Report

    Report Number
    3006630150-2024-01749
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    February 28, 2024
    Report Date
    March 25, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789550
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION. UPN: (B)(4). MODEL: SC-3138-35. SERIAL:(B)(6). BATCH: 7082914.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS HEART RATE DROPPED DURING A PERMANENT IMPLANT PROCEDURE. THE IMPLANTED LEAD AND LEAD EXTENSIONS WERE REMOVED AND PATIENT WAS SENT TO THE HOSPITAL AND RECOVERING WELL. THE EXPLANTED DEVICES WILL NOT BE RETURNED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436108 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50 7079209 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention