BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR 3-4

    MDR report key: 12373609 · Received August 26, 2021

    Report

    Report Number
    3006630150-2021-04776
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    August 4, 2021
    Report Date
    November 8, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789550
    PMA / PMN Number
    P030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352500 MODEL: SC-2352-50 SERIAL: (B)(6). BATCH: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF THERAPY. HIGH IMPEDANCES WERE NOTED ON ONE OF THE TWO LEADS. AN X-RAY REVEALED THAT ONE OF THE LEADS WAS FRACTURED. THE PATIENT HAD A PARTICULARLY VIOLENT SNEEZE THAT MAY HAVE CAUSED IT. IT IS NOT KNOWN WHICH OF THE TWO LEADS HAD THE HIGH IMPEDANCES AND FRACTURE. IT WAS NOTED THAT DURING THE PERMANENT IMPLANT PROCEDURE, THE LEADS WERE SUTURED, NOT ANCHORED. REPROGRAMMING WILL BE PERFORMED TO AVOID THE DAMAGED LEAD. THE LEADS REMAIN IMPLANTED AND THERE IS NO INTENTION TO SURGICALLY REVISE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(4), BATCH: 7072748.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF THERAPY. HIGH IMPEDANCES WERE NOTED ON ONE OF THE TWO LEADS. AN X-RAY REVEALED THAT ONE OF THE LEADS WAS FRACTURED. THE PATIENT HAD A PARTICULARLY VIOLENT SNEEZE THAT MAY HAVE CAUSED IT. IT IS NOT KNOWN WHICH OF THE TWO LEADS HAD THE HIGH IMPEDANCES AND FRACTURE. IT WAS NOTED THAT DURING THE PERMANENT IMPLANT PROCEDURE, THE LEADS WERE SUTURED, NOT ANCHORED. REPROGRAMMING WILL BE PERFORMED TO AVOID THE DAMAGED LEAD. THE LEADS REMAIN IMPLANTED AND THERE IS NO INTENTION TO SURGICALLY REVISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270823 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50 7072796 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other