BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11684152 · Received April 19, 2021

    Report

    Report Number
    3006630150-2021-01627
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    July 23, 2020
    Report Date
    May 10, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS COMPLAINING OF DISCOMFORT IN THE FOOT. THE PHYSICIAN FELT IT BEST TO EXPLANT THE DEVICE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: (B)(4), MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7042576.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586852 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 357460 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention