BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9581129 · Received January 13, 2020

    Report

    Report Number
    3006630150-2019-07955
    Event Type
    Injury
    Date Received
    January 13, 2020
    Date of Event
    December 6, 2019
    Report Date
    January 13, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-9208-15, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7022679/7025227, MODEL/CATALOG DESCRIPTION: PRECISION S8 ADAPTER 15CM. THE EXPLANTED DEVICES 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 MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD INFECTION. SYMPTOM OF PAIN AND REDNESS AT THE POCKET SITE WERE NOTED. IT WAS ALSO REPORTED THAT THE CAUSE OF INFECTION WAS UNKNOWN, AND NOTHING HAPPENED DURING THE SURGERY THAT COULD CAUSE INFECTION. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46654 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 358590 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention