BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 10975737 · Received December 9, 2020

    Report

    Report Number
    3006630150-2020-06069
    Event Type
    Injury
    Date Received
    December 9, 2020
    Date of Event
    November 19, 2020
    Report Date
    December 9, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 7072167.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY AFTER AN SCS IMPLANT PROCEDURE, PRIOR TO THE HOSPITAL DISCHARGE, THE NURSE DISCOVERED TWO CONTACTS OF THE DISTAL TIP OF THE PATIENTS RIGHT LEAD PERFORATED THE SKIN AND WERE EXPOSED. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE WHERE THE LEAD WAS SANITIZED AND REINSERTED INTO THE PATIENT. THE PATIENT WAS DOING GREAT POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440585 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 7072053 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R