BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 9241483 · Received October 25, 2019

    Report

    Report Number
    3006630150-2019-06004
    Event Type
    Injury
    Date Received
    October 25, 2019
    Date of Event
    October 8, 2019
    Report Date
    October 25, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    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) 2019 WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. MODEL NUMBER/CATALOG NUMBER:SC-2138-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: A02084/A02417, MODEL/CATALOG DESCRIPTION: PHASE III LINEAR LEAD - 50CM. MODEL NUMBER/CATALOG NUMBER:SC-2138-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 100060/100126, MODEL/CATALOG DESCRIPTION: PHASE III LINEAR LEAD - 70CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATE 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
    1034597 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 801208

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention