BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9267607 · Received November 1, 2019

    Report

    Report Number
    3006630150-2019-06147
    Event Type
    Injury
    Date Received
    November 1, 2019
    Date of Event
    October 15, 2019
    Report Date
    November 1, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8336-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7051301, MODEL/CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY MEDICAL FACILITY. 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 ONLY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTED MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED AN INFECTION AT THE POCKET SITE. SYMPTOMS OF REDNESS AND SWELLING WERE NOTED AT THE POCKET SITE. IT WAS UNKNOWN WHAT CAUSED THE INFECTION. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063843 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 357868 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention