BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 8893735 · Received August 14, 2019

    Report

    Report Number
    3006630150-2019-04277
    Event Type
    Injury
    Date Received
    August 14, 2019
    Date of Event
    July 29, 2019
    Report Date
    August 14, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6) YEARS OLD. MODEL NUMBER/CATALOG NUMBER: SC-2138-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: A41466/A41531, MODEL/CATALOG DESCRIPTION: PHASE III LINEAR LEAD - 70CM. MODEL NUMBER/CATALOG NUMBER: SC-2158-50T, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 210887/210891, MODEL/CATALOG DESCRIPTION: ENH P3A LD KIT. 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 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
    688179 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 185714 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention