BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 10010884 · Received April 29, 2020

    Report

    Report Number
    3006630150-2020-01925
    Event Type
    Injury
    Date Received
    April 29, 2020
    Date of Event
    April 10, 2020
    Report Date
    April 29, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/ CATALOG NUMBER: SC-2218-70, SERIAL NUMBER: (B)(4), BATCH/ LOT NUMBER: 5111288, MODEL/ CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. MODEL NUMBER/ CATALOG NUMBER: SC-4316, BATCH/ LOT NUMBER: 23926532, MODEL/ CATALOG DESCRIPTION: CLIK ANCHOR. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT REVISION PROCEDURE WHEREIN THE LEADS AND ANCHORS WERE EXPLANTED DUE TO IMPROPER HEALING OF THE INCISION. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471974 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 5117207 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention