BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9613248 · Received January 21, 2020

    Report

    Report Number
    3006630150-2020-00128
    Event Type
    Injury
    Date Received
    January 21, 2020
    Date of Event
    December 27, 2019
    Report Date
    January 21, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5153653/5153692, 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 RELATE TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING POST PERMANENT IMPLANT PROCEDURE THE PATIENT WAS EXPERIENCING LEFT FOOT PAIN. IT WAS ALSO REPORTED THAT THE PHYSICIAN DID NOT MENTION ANYTHING WAS DEVICE RELATED AND UNSURE OF ITS CAUSE. THE PHYSICIAN WAS ALSO UNAWARE OF ANY ISSUE FROM THE RECENT PROCEDURE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74186 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 363257 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention