BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 7674398 · Received July 10, 2018

    Report

    Report Number
    3006630150-2018-60077
    Event Type
    Injury
    Date Received
    July 10, 2018
    Date of Event
    June 13, 2018
    Report Date
    August 9, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO LEAD MIGRATION.THE CAUSE OF MIGRATION WAS UNKNOWN. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN BOTH LEAD WAS REPOSITIONED BUT WAS NOT ABLE TO DO SO DUE TO SCAR TISSUE. THE PHYSICIAN ENDED UP EXPLANTING ONE LEAD AND THE OTHER LEAD WAS PLACED MIDLINE.MODEL NUMBER/CATALOG NUMBER: SC-2215-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER : 7009766, MODEL/CATALOG DESCRIPTION: LINEAR ST. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEAD REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATE TO THE EVENT OCCURRED DURING THE MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENTS LEAD HAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENTS LEAD HAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515699 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 5035436 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention