BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 12800538 · Received November 11, 2021

    Report

    Report Number
    3006630150-2021-06387
    Event Type
    Injury
    Date Received
    November 11, 2021
    Date of Event
    September 3, 2021
    Report Date
    November 11, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI, UPN: M365SC8416700, MODEL: SC-8416-70, SERIAL: (B)(4), BATCH: 7052810.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) SYSTEM WAS NOT PROVIDING ADEQUATE PAIN RELIEF. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG SITE. ALL DEVICE COMPONENTS WERE EXPLANTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS IT WAS KEPT BY MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699333 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 365222 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention