BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 17159693 · Received June 19, 2023

    Report

    Report Number
    3006630150-2023-03501
    Event Type
    Injury
    Date Received
    June 19, 2023
    Date of Event
    May 31, 2023
    Report Date
    June 19, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789581
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: N/A, UPN: M365SC3138350, MODEL: SC-3138-35, SERIAL: (B)(6), BATCH: 7080997.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE SECOND STAGE PROCEDURE TO IMPLANT THE IMPLANTABLE PULSE GENERATOR (IPG), THE PHYSICIAN FOUND THE CONNECTOR OF THE LEAD EXTENSION BENT WITH THE LEAD CONNECTOR INSIDE. THE LEAD COULD NOT BE REMOVED FROM THE EXTENSION AS IT WAS BENT SO HARD THAT THE PART BETWEEN CONTACTS 3 AND 4 HAD A BUMP ON THE CONNECTOR OF THE LEAD. THE PHYSICIAN SUSPECTED THAT THERE WAS STRONG TENSION ON THE CABLE/EXTENSION OUTSIDE THE BODY PRIOR TO THE PROCEDURE THAT MAY HAVE CAUSED THE BEND. THE LEAD AND LEAD EXTENSION WERE REMOVED, A NEW LEAD WAS SUCCESSFULLY CONNECTED TO THE IPG. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458501 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-70 7076984 08714729789581

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention