BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 6314218 · Received February 9, 2017

    Report

    Report Number
    3006630150-2017-00451
    Event Type
    Injury
    Date Received
    February 9, 2017
    Date of Event
    January 19, 2017
    Report Date
    January 19, 2017
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN REMOVED THE GRANULOMA AND PERFORMED SURGICAL WOUND REMODELING ON (B)(6) 2017. THERE WAS NOTHING REPLACED OR ADDED. THE PATIENT IS REPORTEDLY DOING GOOD FOLLOWING THE PROCEDURE. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-70, SERIAL # (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2218-70 SERIAL/LOT # 3022533 DESCRIPTION: LINEAR ST LEAD, 70CM ADDITIONAL INFORMATION WAS RECEIVED THAT THE WOUND CONTINUES WITH GRANULOMA. THE PHYSICIAN ASSESSED THAT THE GRANULOMA IS RELATED WITH THE LEADS BECAUSE THE PROBLEM HAS ALWAYS BEEN IN THE WOUND OF THE LEADS. THE PATIENT WILL UNDERGO A REVISION PROCEDURE AND IF AFTER THAT, IT DOES NOT IMPROVE, THE PHYSICIAN WILL EXPLANT THE SYSTEM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO THEIR SURGICAL WOUND BEING VERY RED. THE PHYSICIAN BELIEVED THAT THE PATIENT'S SYMPTOM WAS DUE TO A REJECTION OF THEIR IMPLANTED DEVICES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO THEIR SURGICAL WOUND BEING VERY RED. THE PHYSICIAN BELIEVED THAT THE PATIENT'S SYMPTOM WAS DUE TO A REJECTION OF THEIR IMPLANTED DEVICES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO THEIR SURGICAL WOUND BEING VERY RED. THE PHYSICIAN BELIEVED THAT THE PATIENT'S SYMPTOM WAS DUE TO A REJECTION OF THEIR IMPLANTED DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103375 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention