BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 17652673 · Received August 30, 2023

    Report

    Report Number
    3006630150-2023-05187
    Event Type
    Injury
    Date Received
    August 30, 2023
    Date of Event
    August 7, 2023
    Report Date
    August 30, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789581
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION; UPN: M365SC3138350; MODEL: SC-3138-35; SERIAL: (B)(6); BATCH: 7081429. PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2352700; MODEL: SC-2352-70; SERIAL: (B)(6); BATCH: 7077107. PRODUCT FAMILY: SCS-NON-SURG ACC; UPN: M365SC41080; MODEL: SC-4108; SERIAL: N/A; BATCH: 29825286. PRODUCT FAMILY: SCS-EXTENSION; UPN: M365SC3138350; MODEL: SC-3138-35; SERIAL: (B)(6); BATCH: 7081427.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A PERMANENT SCS SYSTEM IMPLANT PROCEDURE AND THE PATIENTS LEADS EXHIBITED HIGH IMPEDANCES. THE PHYSICIAN TESTED THE OPERATING ROOM (OR) CABLE SEVERAL TIMES AND CLEANED THE ENDS OF THE LEAD EXTENSIONS SEVERAL TIMES, BUT THE HIGH IMPEDANCES REMAINED, EVEN WITH A NEW OR CABLE. THE PHYSICIAN DECIDED TO PERFORM A REVISION PROCEDURE THE NEXT DAY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE PHYSICIAN SEPARATED THE EXTENSIONS FROM THE LEADS AND CLEANED THEM SEVERAL TIMES BEFORE RECONNECTING THEM. AFTER THE PHYSICIAN RECONNECTED ALL THE CONTACTS, THE PATIENTS HIGH IMPEDANCES WERE RESOLVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680346 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-70 7077106 08714729789581

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention