BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10927086 · Received December 1, 2020

    Report

    Report Number
    3006630150-2020-05940
    Event Type
    Injury
    Date Received
    December 1, 2020
    Date of Event
    November 11, 2020
    Report Date
    June 4, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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-PADDLE LEADS, UPN: (B)(4), MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7072370.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A NON-DEVICE RELATED INFECTION AT THE BATTERY SITE. THE SYMPTOMS WERE REDNESS AND TENDERNESS AROUND THE POCKET SITE WHICH COULD HAVE BEEN DUE TO THE MEDICATION THAT WAS NOT SUPPOSED TO BE APPLIED AT THE INCISION SITE AS PER PHYSICIAN. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT A FULL SYSTEM EXPLANT PROCEDURE. THE EXPLANTED IPG AND PADDLE LEAD WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391823 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 371893 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention