BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 8876249 · Received August 8, 2019

    Report

    Report Number
    3006630150-2019-04156
    Event Type
    Injury
    Date Received
    August 8, 2019
    Date of Event
    January 1, 2016
    Report Date
    August 8, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE (B)(6) 2016 WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. EXPLANT DATE: 2016. CONCOMITANT MEDICAL PRODUCTS: MODEL NUMBER/CATALOG NUMBER: SC-2208-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 175483/182846, MODEL/CATALOG DESCRIPTION: ST LINEAR LEAD 50CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENTS DEVICE WAS NO LONGER WORKING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668874 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 167575

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention