BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 12224879 · Received July 26, 2021

    Report

    Report Number
    3006630150-2021-04040
    Event Type
    Injury
    Date Received
    July 26, 2021
    Date of Event
    November 5, 2020
    Report Date
    September 27, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE STIMULATION. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT LIKE THE TINGLING SENSATION.

    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: 7083232/7083368.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE STIMULATION. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121106 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 372040 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention