BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9338743 · Received November 18, 2019

    Report

    Report Number
    3006630150-2019-06615
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    October 31, 2019
    Report Date
    January 3, 2020
    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 · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS INFECTION WAS NOT DEVICE RELATED AND THE CAUSE WAS UNKNOWN.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENTS BATTERY SITE WAS SWELLING. IT WAS ALSO REPORTED THAT THE PATIENT WAS DIAGNOSED WITH INFECTION. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTIC AND UNDERWENT EXPLANT.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8336-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7062805, MODEL/CATALOG DESCRIPTION: COVEREDGE 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 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 PATIENTS BATTERY SITE WAS SWELLING. IT WAS ALSO REPORTED THAT THE PATIENT WAS DIAGNOSED WITH INFECTION. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTIC AND UNDERWENT EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128619 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 355740 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention