BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 8903843 · Received August 16, 2019

    Report

    Report Number
    3006630150-2019-04356
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    July 26, 2019
    Report Date
    August 16, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2108-50 M, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 17398/17690, MODEL/CATALOG DESCRIPTION: SCS LEAD KIT, PHASE 2 STERILE PACKAGE. MODEL NUMBER/CATALOG NUMBER: SC-2138-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 103742/15317, MODEL/CATALOG DESCRIPTION: PHASE III LINEAR LEAD - 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATE TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WERE FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HOSPITALIZED DUE TO AN INFECTION. IT WAS NOTED THAT PATIENT HAD LEAKING BODILY FLUIDS FROM THE POCKET SITE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS CAUSED BY AN OPEN WOUND AT THE POCKET SITE AND SPREAD THROUGHOUT THE LEAD SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS PLACED ON ANTIBIOTICS, THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697051 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 702411

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R