BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8617993 · Received May 16, 2019

    Report

    Report Number
    3006630150-2019-02303
    Event Type
    Injury
    Date Received
    May 16, 2019
    Date of Event
    April 29, 2019
    Report Date
    May 16, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2317-50; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 5092457/5092461; MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATE TO THE EVENT OCCURRED DURING THE MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD POSSIBLE INFECTION AND DEVELOPED LESIONS THAT WERE FLUFFY AT THE SURGICAL SITE. IT WAS ALSO REPORTED THAT THE ORIGINAL INCISION HAVE NOT STILL FULLY HEALED. THE PHYSICIAN WAS HARD TO TELL IF IT WAS INFECTED AND THEY WERE SENDING IT TO PATHOLOGY AND DID NOT BELIEVED THAT IT WAS PROCEDURE RELATED. THE PATIENT UNDERWENT AN IPG AND LEADS EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408991 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 345217 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention