BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8725314 · Received June 21, 2019

    Report

    Report Number
    3006630150-2019-02967
    Event Type
    Injury
    Date Received
    June 21, 2019
    Date of Event
    June 5, 2019
    Report Date
    June 21, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8336-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7041913, MODEL/CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 50 CM. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION IN THE SKIN AROUND POCKET SITE. SYMPTOM OF REDNESS WAS NOTED. THE PHYSICIAN CONFIRMED THAT THE INFECTION WAS NOT DEVICE RELATED AND THE CAUSE WAS RARE BACTERIA ON THE SKIN. IT WAS BELIEVED THAT NOTHING HAPPENED DURING THE PROCEDURE. THE PATIENTS WAS PLACED ON ANTIBIOTICS AND UNDERWENT AN EXPLANT. THE PATIENT WAS DOING WELL POSTOPERATIVELY. NO FURTHER INFORMATION COULD BE OBTAINED AT TTHIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517577 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 347403 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention