BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 16445464 · Received February 27, 2023

    Report

    Report Number
    3006630150-2023-00875
    Event Type
    Injury
    Date Received
    February 27, 2023
    Date of Event
    December 19, 2022
    Report Date
    February 27, 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

    EVENT DATE: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 7070177; PRODUCT FAMILY: SCS-IPG-R, UPN: M365SC11600, MODEL: SC-1160, SERIAL: (B)(4), BATCH: 377896; PRODUCT FAMILY: SCS-ADAPTERS, UPN: M365SC9218150, MODEL: SC-9218-15, SERIAL: (B)(4), BATCH: 7070229; PRODUCT FAMILY: SCS-ADAPTERS, UPN: M365SC9218150, MODEL: SC-9218-15 , SERIAL: (B)(4), BATCH: 7071459.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT WAS IMPLANTED WITH TWO M8 ADAPTORS CONNECTED TO A NON-BSC PADDLE LEAD AND WAS EXPERIENCING ABDOMINAL STIMULATION WHEN TRYING TO INCREASE PARESTHESIA IN THE LOWER BACK, COCCYX AND BILATERAL LEGS. THE PATIENT WAS ALSO IMPLANTED WITH CERVICAL PERIPHERAL NERVE STIMULATION (PNS) LEADS AND WAS EXPERIENCING NECK AND SHOULDER MUSCLE CONTRACTIONS. THE SCS SYSTEM WAS REPROGRAMMED WHICH IMPROVED COVERAGE AND LESSENED THE ABDOMINAL STIMULATION AND THE PNS LEADS WERE TURNED OFF. A WEEK LATER THE PATIENT INDICATED NOT RECEIVING A BENEFIT FROM THE REPROGRAMMING. THE PATIENT UNDERWENT A REPLACEMENT OF THE SCS SYSTEM AND EXPLANT OF THE PNS LEADS. THE PATIENT WAS DOING FINE POST-OPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788201 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 7071294 08714729789567

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention