BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8061354 · Received November 12, 2018

    Report

    Report Number
    3006630150-2018-61754
    Event Type
    Injury
    Date Received
    November 12, 2018
    Date of Event
    October 19, 2018
    Report Date
    November 12, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: MODEL NUMBER/CATALOG NUMBER: SC-2218-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 560092 / 5060525, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 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 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 NOTICED THAT A SMALL AMOUNT OF CLEAR LIQUID WAS SEEPING FROM THE IPG INCISION SITE. THE PHYSICIAN BELIEVED THAT THE PATIENT DEVELOPED AN INFECTION. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899119 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 333839 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention