BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8044668 · Received November 6, 2018

    Report

    Report Number
    3006630150-2018-61675
    Event Type
    Injury
    Date Received
    November 6, 2018
    Date of Event
    October 17, 2018
    Report Date
    November 26, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: MODEL NUMBER/CATALOG NUMBER: SC-8352-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7020808, MODEL/CATALOG DESCRIPTION: COVEREDGE X 32 SURGICAL LEAD KIT 50 CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN SCS EXPLANT PROCEDURE. MODEL NUMBER/CATALOG NUMBER: SC-8352-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7020808, MODEL/CATALOG DESCRIPTION: COVEREDGE X 32 SURGICAL LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE 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 MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HEADED TO THE EMERGENCY ROOM PER IMPLANTING PHYSICIANS DISCRETION. IT WAS REPORTED THAT THE PHYSICIAN WAS CONCERNED ABOUT THE POSSIBILITY OF EITHER AN INFECTION AT BOTH SURGICAL SITES OR AN ALLERGIC REACTION. SYMPTOMS OF IRRITATION ON BOTH SITES WERE NOTED. IT WAS BELIEVED THAT THE INFECTION SYMPTOMS WERE NOT PRESENT AND THE PHYSICIAN FELT THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION. THE PATIENT WAS PRESCRIBED WITH STEROIDS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HEADED TO THE EMERGENCY ROOM PER IMPLANTING PHYSICIANS DISCRETION. IT WAS REPORTED THAT THE PHYSICIAN WAS CONCERNED ABOUT THE POSSIBILITY OF EITHER AN INFECTION AT BOTH SURGICAL SITES OR AN ALLERGIC REACTION. SYMPTOMS OF IRRITATION ON BOTH SITES WERE NOTED. IT WAS BELIEVED THAT THE INFECTION SYMPTOMS WERE NOT PRESENT AND THE PHYSICIAN FELT THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION. THE PATIENT WAS PRESCRIBED WITH STEROIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884605 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 335680 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R