BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR ST

    MDR report key: 9990181 · Received April 23, 2020

    Report

    Report Number
    3006630150-2020-01863
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    March 27, 2020
    Report Date
    October 22, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS FEELING LEADS PULLING AND WAS HAVING REDNESS. THE PATIENT WAS EXPERIENCING BACK PAIN AND LOSS OF STIMULATION. X-RAY REVEALED THAT ONE OF THE LEADS WAS BROKEN. ADDITIONAL INFORMATION WAS RECEIVED THAT BOTH LEADS WERE EXPLANTED AND WILL NOT BE RETURNED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS FEELING LEADS PULLING AND WAS HAVING REDNESS. THE PATIENT WAS EXPERIENCING BACK PAIN AND LOSS OF STIMULATION. X-RAY REVEALED THAT ONE OF THE LEADS WAS BROKEN.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-70, SERIAL NUMBER: (B)(4), BATCH/ LOT NUMBER: 5030039, MODEL/ CATALOG DESCRIPTION: LINEAR LEAD KIT 70 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS FEELING LEADS PULLING AND WAS HAVING REDNESS. THE PATIENT WAS EXPERIENCING BACK PAIN AND LOSS OF STIMULATION. X-RAY REVEALED THAT ONE OF THE LEADS WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453701 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 5029158 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention