BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 9137875 · Received September 30, 2019

    Report

    Report Number
    3006630150-2019-05432
    Event Type
    Injury
    Date Received
    September 30, 2019
    Date of Event
    January 1, 2012
    Report Date
    September 30, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    P030017
    Adverse Event
    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) 2012 WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. EXPLANT DATE: 2012. MODEL NUMBER / CATALOG NUMBER: SC-2218-70, SERIAL NUMBER: (B)(4), BATCH / LOT NUMBER: 207705/221479, MODEL / CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS AND IPG 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 PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR AN UNKNOWN REASON. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929121 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 196134 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention