BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 10011906 · Received April 29, 2020

    Report

    Report Number
    3006630150-2020-01928
    Event Type
    Injury
    Date Received
    April 29, 2020
    Date of Event
    March 26, 2020
    Report Date
    May 22, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN CONFIRMED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED AND THE CAUSE WAS UNKNOWN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE MIDLINE INCISION SITE AND THE PHYSICIAN HAD PACKED THE PATIENTS WOUND. UPON FOLLOW-UP, THE PHYSICIAN CONFIRMED THAT THE WOUND LOOKED NOT INFECTED. HOWEVER, THE WOUND WAS DEEPER AND HAD MORE TRACKING AS THE PATIENT HAD NOT BEEN GETTING WOUND CARE WITH PACKING.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: MODEL NUMBER/CATALOG NUMBER: SC-2218-70; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 5172947; MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE MIDLINE INCISION SITE AND THE PHYSICIAN HAD PACKED THE PATIENTS WOUND. UPON FOLLOW-UP, THE PHYSICIAN CONFIRMED THAT THE WOUND LOOKED NOT INFECTED. HOWEVER, THE WOUND WAS DEEPER AND HAD MORE TRACKING AS THE PATIENT HAD NOT BEEN GETTING WOUND CARE WITH PACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475421 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 5170598 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention