BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10896304 · Received November 24, 2020

    Report

    Report Number
    3006630150-2020-05792
    Event Type
    Injury
    Date Received
    November 24, 2020
    Date of Event
    August 22, 2019
    Report Date
    November 24, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. 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: 5070940/5082226.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY CHARGING IPG AND WAS EXPERIENCING DISCOMFORT DUE TO WEIGHT LOSS WHICH WAS SAID TO BE DEVICE RELATED. THE PATIENT UNDERWENT A FULL SYSTEM EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358524 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 345283 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention