BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 12736861 · Received November 2, 2021

    Report

    Report Number
    3006630150-2021-06144
    Event Type
    Injury
    Date Received
    November 2, 2021
    Date of Event
    October 13, 2021
    Report Date
    November 2, 2021
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 5070399/ 5070877/ 7070468. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC236670, MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 7070616. PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC313825, MODEL: SC-3138-25, SERIAL: (B)(4), BATCH: 7070333/7070355.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING INADEQUATE PAIN RELIEF. ALL DEVICES WERE EXPLANTED AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635578 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW SC-1160 367918 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention