BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 9305808 · Received November 11, 2019

    Report

    Report Number
    3006630150-2019-06398
    Event Type
    Injury
    Date Received
    November 11, 2019
    Date of Event
    November 16, 2009
    Report Date
    November 28, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE (B)(6) 2013 WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. EXPLANT DATE: 2013. MODEL NUMBER/CATALOG NUMBER: SC-2208-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 147625/172294/163227/163249, MODEL/CATALOG DESCRIPTION: ST LINEAR LEAD 70CM. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES 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 MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098644 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 164133

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention