BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 9021118 · Received September 13, 2019

    Report

    Report Number
    3006630150-2019-05029
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    May 9, 2019
    Report Date
    September 13, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 204778/203753, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. MODEL NUMBER/CATALOG NUMBER: SC-3138-55, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 156807/156781, MODEL/CATALOG DESCRIPTION: LEAD EXTENSION KIT, 55CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENTS SCS WAS CAUSING COMPLICATIONS. THE PATIENT UNDERWENT EXPLANT PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817500 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 179787

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention