BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9453992 · Received December 11, 2019

    Report

    Report Number
    3006630150-2019-07275
    Event Type
    Injury
    Date Received
    December 11, 2019
    Date of Event
    November 22, 2019
    Report Date
    December 11, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5142341/5142451, 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 DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WAS FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE. SYMPTOM OF DRAINAGE WAS NOTED. THE PHYSICIAN CONFIRMED THAT THE INFECTION WAS NOT PROCEDURE RELATED HOWEVER, IT WAS UNKNOWN IF IT WAS DEVICE RELATED AND WHAT CAUSED IT. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244214 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 358545 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention