BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 9567446 · Received January 9, 2020

    Report

    Report Number
    3006630150-2020-00020
    Event Type
    Injury
    Date Received
    January 9, 2020
    Date of Event
    December 13, 2019
    Report Date
    January 9, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729760559
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-3138-35, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7042676, MODEL/CATALOG DESCRIPTION:LEAD EXTENSION KIT 35CM. THE EXPLANTED LEAD EXTENSIONS WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENTS LEAD EXTENSIONS WERE CAUSING DISCOMFORT AROUND THE BELT LINE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN LEAD EXTENSIONS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32165 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-3138-35 7042639 08714729760559

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention