BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10380347 · Received August 7, 2020

    Report

    Report Number
    3006630150-2020-03305
    Event Type
    Injury
    Date Received
    August 7, 2020
    Date of Event
    July 8, 2020
    Report Date
    August 7, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7072417. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: (B)(4), MODEL: SC-2408-74, SERIAL: (B)(4), BATCH: 5151257.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING NUMBNESS AND DISCOMFORT AT THE LEFT UPPER EXTREMITIES FOLLOWING AN IMPLANT PROCEDURE. THE PHYSICIAN BELIEVED IT WAS DUE TO SWELLING RELATED TO THE PROCEDURE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND THE PATIENT HAD FULLY RECOVERED POSTOPERATIVELY. ALL DEVICE COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845589 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 369095 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention