BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 17655748 · Received August 30, 2023

    Report

    Report Number
    3006630150-2023-05196
    Event Type
    Injury
    Date Received
    August 30, 2023
    Date of Event
    August 1, 2023
    Report Date
    October 13, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789567
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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)(6), BATCH: 7073155.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366700, MODEL: SC-2366-70, BATCH/ SERIAL: (B)(6). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366700, MODEL: SC-2366-70. BATCH/ SERIAL: (B)(6). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366700, MODEL: SC-2366-70, BATCH/ SERIAL: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE TO EXPLANT AND REPLACE THE LEADS DUE TO HIGH IMPEDANCE. TWO NEW LEADS WERE IMPLANTED. THE MEDICAL FACILITY DISCARDED THE EXPLANTED LEADS. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND FULLY RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED THAT ONLY TWO LEADS WERE EXPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE TO EXPLANT AND REPLACE THE LEADS DUE TO HIGH IMPEDANCE. TWO NEW LEADS WERE IMPLANTED. THE MEDICAL FACILITY DISCARDED THE EXPLANTED LEADS. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND FULLY RECOVERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE TO EXPLANT AND REPLACE THE LEADS DUE TO HIGH IMPEDANCE. TWO NEW LEADS WERE IMPLANTED. THE MEDICAL FACILITY DISCARDED THE EXPLANTED LEADS. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302080 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 7073119 08714729789567

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention