BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11744891 · Received April 29, 2021

    Report

    Report Number
    3006630150-2021-01843
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    February 4, 2021
    Report Date
    April 29, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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-2218-70, SERIAL: (B)(4), BATCH: 7072339/7072383/7072494.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE IPG SITE DUE TO WEIGHT LOSS, INADEQUATE STIMULATION WAS ALSO NOTED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640183 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 367847 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention