BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8819500 · Received July 23, 2019

    Report

    Report Number
    3006630150-2019-03769
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    June 27, 2019
    Report Date
    July 23, 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-2317-70. SERIAL NUMBER: (B)(4). BATCH/LOT NUMBER: 5082216/5082370. MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 70CM. 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 ARE 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 DEVELOPED AN INFECTION AT THE IPG POCKET SITE AFTER A RECENT REVISION (MFR NO. 3006630150-2018-62622). SYMPTOMS OF POCKET SITE DISCOMFORT AND PRESENCE OF DISCHARGES WERE NOTED. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING OVERSTIMULATION AT THE IPG SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609692 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 344372 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention