BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10284276 · Received July 16, 2020

    Report

    Report Number
    3006630150-2020-02947
    Event Type
    Injury
    Date Received
    July 16, 2020
    Date of Event
    May 13, 2020
    Report Date
    July 16, 2020
    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

    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: 7072177/7072416.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM DUE TO FALL THAT LEFT A CUT ON THE BATTERY SITE. IT WAS NOTED THAT PATIENT WAS PUTTING COINS INTO THE BATTERY INCISION ALONG WITH SPOON. THE PHYSICIANS ASSISTANT DESCRIBED THE INDUCTION AS PRECISELY CUT ALONG THE ORIGINAL INCISION LINE THAT WAS MADE BY THE PHYSICIAN AND SAID IT TO BE SELF INFLICTED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND UNDERWENT A FULL SYSTEM EXPLANT DUE TO AN OPEN WOUND, BACTERIA FROM COINS AND SPOON BEING PLACED IN, DRAINAGE AND POSSIBILITY OF INFECTION. ALL EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747990 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 362946 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention