BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 10066389 · Received May 18, 2020

    Report

    Report Number
    3006630150-2020-02097
    Event Type
    Injury
    Date Received
    May 18, 2020
    Date of Event
    April 28, 2014
    Report Date
    May 18, 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 PROVIDED EVENT DATE (B)(6) 2014 WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. MODEL NUMBER/CATALOG NUMBER: SC-2208-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 177181 / 182746, MODEL/CATALOG DESCRIPTION: ST LINEAR LEAD 50 CM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING WORSENING OF PAIN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530305 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 173854

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention