BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 11975385 · Received June 10, 2021

    Report

    Report Number
    3006630150-2021-02822
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    April 20, 2021
    Report Date
    June 10, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789567
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 7070629.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AS THE SAME ISSUE REPORTED IN MFR NUMBER 3006630150-2021-01995 HAPPENED AGAIN. THE SAME LEADS HAD PROTRUDED AND PATIENTS WOUND FROM THE RECENT REVISION WAS NOT HEALING PROPERLY. THE EXPLANTED LEADS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870495 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 7070619 08714729789567

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention