BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8198013 · Received December 26, 2018

    Report

    Report Number
    3006630150-2018-62487
    Event Type
    Injury
    Date Received
    December 26, 2018
    Date of Event
    December 11, 2018
    Report Date
    December 26, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-70; SERIAL NUMBER : (B)(4); BATCH/LOT NUMBER: 5063124 / 5063212; MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. 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 MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN SCS EXPLANT PROCEDURE DUE TO AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035367 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 339098 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention