BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9578860 · Received January 10, 2020

    Report

    Report Number
    3006630150-2019-07951
    Event Type
    Injury
    Date Received
    January 10, 2020
    Date of Event
    December 23, 2019
    Report Date
    January 10, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: MODEL NUMBER/CATALOG NUMBER: SC-2218-50; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 5130861/5133972; MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND LEADS 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 IPG POCKET WOUND WAS SITTING AND ERODED. THE PHYSICIAN BELIEVED IT WAS NOT DEVICE RELATED, BUT NOTED THAT THE PATIENT LOST WEIGHT. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37774 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 356568 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention