BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 10993625 · Received December 11, 2020

    Report

    Report Number
    3006630150-2020-06159
    Event Type
    Injury
    Date Received
    December 11, 2020
    Date of Event
    November 19, 2020
    Report Date
    January 25, 2021
    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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED LEADS SC-2352-70 (SERIAL NUMBER (B)(6)) AND SC-2218-70 (SERIAL NUMBER (B)(6)) WERE ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. VISUAL INSPECTION OF SC-2218-70 (SERIAL NUMBER (B)(6)) REVEALED THE PROXIMAL END IS BENT BETWEEN RETENTION AND CONTACT 8. X-RAY INSPECTION OF THE LEAD REVEALED THAT ONE THE CABLES WAS COMPLETELY BROKEN AT THE BENT LOCATION OF THE LEAD. THE CONTACT DEFORMATION RESULTED IN THE INABILITY TO FULLY INSERT THE LEAD PROXIMAL CONTACTS INTO THE IPG PORT. IT APPEARS THAT THE LEAD CONTACT WAS DAMAGED DURING THE PROCEDURE. ANALYSIS OF SC-4318 (LOT NUMBER 23711319) REVEALED BOTH EYELETS OF THE CLICK ANCHOR WERE TORN. IT APPEARS THAT EXCESSIVE MECHANICAL FORCE WAS EXERTED ONTO THE EYELET, CAUSING IT TO RIP. DAMAGE MOST LIKELY OCCURRED DURING THE EXPLANT PROCEDURE. ANALYSIS OF SC-4318 (LOT NUMBER 23327512) REVEALED THAT ONE OF THE CLIK ANCHORS HAS ONE TORN EYELET. IT APPEARS THAT EXCESSIVE MECHANICAL FORCE WAS EXERTED ONTO THE EYELET, CAUSING IT TO RIP. THE ANCHOR IS MOST LIKELY DAMAGED DURING THE EXPLANT PROCEDURE. BASED ON THE PROVIDED INFORMATION, THE INVESTIGATION CONCLUSION IS THAT THE PROBABLE CAUSE IS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING MINIMAL PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE LEADS AND CLIK ANCHORS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 5121162. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2218-70 , SERIAL: (B)(4), BATCH: 5122890. PRODUCT FAMILY: SCS-LEAD FIXATION: UPN: (B)(4), MODEL: SC-4318, SERIAL: N/A, BATCH: 23711319. PRODUCT FAMILY: SCS-LEAD FIXATION: UPN: (B)(4), MODEL: SC-4318, SERIAL: N/A, BATCH: 23327512.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING MINIMAL PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE LEADS AND CLIK ANCHORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458064 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-70 5107835 08714729789581

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention