BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10136139 · Received June 9, 2020

    Report

    Report Number
    3006630150-2020-02409
    Event Type
    Injury
    Date Received
    June 9, 2020
    Date of Event
    March 5, 2020
    Report Date
    June 9, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(4); BATCH: 5122875/5124179.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING ABDOMINAL PAIN AND BELIEVED THAT THE STIMULATOR WAS WORSENING IT. THE PHYSICIAN OFFERED A REPROGRAMMING SESSION, HOWEVER, THE PATIENT DECLINED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595904 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 349219 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention