BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 9074208 · Received September 17, 2019

    Report

    Report Number
    3006630150-2019-05099
    Event Type
    Injury
    Date Received
    September 17, 2019
    Date of Event
    August 30, 2017
    Report Date
    September 16, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    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) 2017 WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. EXPLANT DATE: 2017. MODEL NUMBER/CATALOG NUMBER: SC-2208-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 173447, MODEL/CATALOG DESCRIPTION: ST LINEAR LEAD 50CM. MODEL NUMBER/CATALOG NUMBER: SC-2108-70M, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 10824 , MODEL/CATALOG DESCRIPTION: SCS LEAD KIT, PHASE 2 STERILE PACKAGE. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED WAS RECEIVED THAT THE PATIENTS SCS (SPINAL CORD STIMULATOR) WAS NON-FUNCTIONAL. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868148 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 177711

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention