BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11186125 · Received January 18, 2021

    Report

    Report Number
    3006630150-2021-00043
    Event Type
    Injury
    Date Received
    January 18, 2021
    Date of Event
    January 5, 2021
    Report Date
    January 18, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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, UPN: (B)(4), MODEL: SC-8336-70, SERIAL: (B)(4), BATCH: 7063322.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS INCISION DID NOT HEAL PROPERLY. ALL COMPONENTS WERE EXPLANTED AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82140 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 365928 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention