BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 9092881 · Received September 19, 2019

    Report

    Report Number
    3006630150-2019-05186
    Event Type
    Injury
    Date Received
    September 19, 2019
    Date of Event
    April 15, 2019
    Report Date
    September 19, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729760542
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-3138-25; SERIAL NUMBER: 1082435; BATCH/LOT NUMBER: 19340714; MODEL/CATALOG DESCRIPTION: LEAD EXTENSION KIT 25CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEAD EXTENSIONS 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 WAS EXPERIENCING INADEQUATE STIMULATION DUE TO HIGH IMPEDANCE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD EXTENSIONS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879943 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-3138-25 19340714 08714729760542

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention