BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVEREDGE 32

    MDR report key: 9631453 · Received January 27, 2020

    Report

    Report Number
    3006630150-2020-00188
    Event Type
    Injury
    Date Received
    January 27, 2020
    Date of Event
    January 6, 2020
    Report Date
    January 27, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729832676
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8416-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7052198, MODEL/CATALOG DESCRIPTION: ARTISAN MRI PADDLE LEAD 70 CM. 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 MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENTS MIDLINE INCISION WAS NOT FULLY CLOSED. THE PATIENT UNDERWENT WOUND DEBRIDEMENT. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95039 COVEREDGE 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8336-70 1101588 08714729832676

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention