BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 15094780 · Received July 25, 2022

    Report

    Report Number
    3006630150-2022-03648
    Event Type
    Injury
    Date Received
    July 25, 2022
    Date of Event
    June 22, 2021
    Report Date
    July 25, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789550
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS- LINEAR LEADS; UPN: M365SC2352500; MODEL: SC-2352-50; SERIAL: (B)(4); LOT: 7071364.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNCOMFORTABLE SENSATIONS FROM THE LEFT SPINAL CORD STIMULATION LEAD. AN X-RAY DISPLAYED THE LEFT LEAD HAD MIGRATED DOWN INTO THE SACRAL REGION. REPROGRAMMING THE DEVICE WAS ATTEMPTED, HOWEVER THE ISSUE DID NOT RESOLVE. THE PATIENT THEN UNDERWENT A REVISION PROCEDURE WHERE THE LEFT LEAD WAS REMOVED AND A NEW LEAD WAS PLACED PER THE PHYSICIANS PREFERENCE FOR EASE AND TWO ADDITIONAL LEADS WERE IMPLANTED. THERE WAS NO DEVICE ISSUE OTHER THAN MIGRATION. THE PATIENT RECEIVED ACCURATE THERAPY AND RECOVERED POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1394267 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50 7071361 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention