BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 9244977 · Received October 28, 2019

    Report

    Report Number
    3006630150-2019-06022
    Event Type
    Injury
    Date Received
    October 28, 2019
    Date of Event
    October 8, 2019
    Report Date
    October 28, 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

    MODEL NUMBER/CATALOG NUMBER: SC-2218-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 243661/243645, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. MODEL NUMBER/CATALOG NUMBER: SC-2138-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: A30228/A30359/A30456, MODEL/CATALOG DESCRIPTION: PHASE III LINEAR LEAAD - 70CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND THE 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
    1041834 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 168816

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention