BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10323393 · Received July 24, 2020

    Report

    Report Number
    3006630150-2020-03077
    Event Type
    Injury
    Date Received
    July 24, 2020
    Date of Event
    March 5, 2020
    Report Date
    July 24, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 7071008/7071021.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING AN IMPLANT PROCEDURE THE PATIENT WAS HAVING PAIN AT THE IPG SITE AND WAS FEELING A PULSATING PAIN WHERE LEADS ARE LOCATED AND OCCURS WHETHER STIMULATION WAS ON OR OFF. THE PHYSICIAN BELIEVED THAT PAIN WAS CAUSED BY NERVE IRRITATION. THERE WAS NO DEVICE MALFUNCTION SUSPECTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL DEVICE COMPONENTS WERE EXPLANTED AND WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787475 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 365854 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention