BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 9991347 · Received April 23, 2020

    Report

    Report Number
    3006630150-2020-01865
    Event Type
    Injury
    Date Received
    April 23, 2020
    Date of Event
    April 1, 2011
    Report Date
    April 23, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE (B)(6) 2011 WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. MODEL NUMBER/CATALOG NUMBER: SC-8116-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 134278, MODEL/CATALOG DESCRIPTION: ARTISAN SURGICAL LEAD, 70 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE IPG SITE. IT WAS ALSO NOTED THAT THE PATIENT HAD INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455924 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 161797

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention