BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 9078470 · Received September 17, 2019

    Report

    Report Number
    3006630150-2019-05106
    Event Type
    Injury
    Date Received
    September 17, 2019
    Date of Event
    January 1, 2009
    Report Date
    September 17, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE (B)(6) 2009 WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. MODEL NUMBER/CATALOG NUMBER: SC-2208-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 173601, MODEL/CATALOG DESCRIPTION: ST LINEAR LEAD 50CM. MODEL NUMBER/CATALOG NUMBER: SC-3138-25, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: A08432, MODEL/CATALOG DESCRIPTION: LEAD EXTENSION KIT 25CM. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES 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 PATIENTS STIMULATOR DID NOT WORK. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869834 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 165900

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention