BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 10440522 · Received August 22, 2020

    Report

    Report Number
    3006630150-2020-03573
    Event Type
    Injury
    Date Received
    August 22, 2020
    Date of Event
    July 27, 2020
    Report Date
    August 22, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT DEVICES: PRODUCT FAMILY SCS-LINEAR LEADS: UPN M365SC2366700, MODEL SC-2366-70, SERIAL (B)(4), BATCH 5136368. PRODUCT FAMILY SCS-LINEAR LEADS: UPN M365SC2366700, MODEL SC-2366-70, SERIAL (B)(4), BATCH 5142486. PRODUCT FAMILY SCS-LINEAR LEADS: UPN M365SC2366700, MODEL SC-2366-70, SERIAL (B)(4), BATCH 5142000.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REPOSITIONING PROCEDURE AND WAS DOING WELL POST-OPERATIVELY. NO DEVICES WERE IMPLANTED OR EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904847 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 21584987 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention