BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 9387350 · Received November 27, 2019

    Report

    Report Number
    3006630150-2019-06867
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    November 6, 2019
    Report Date
    November 27, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: MODEL NUMBER/CATALOG NUMBER:SC-2218-50E; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 7071162; MODEL/CATALOG DESCRIPTION:LINEAR ST TRIAL LEAD KIT 50 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 FOLLOWING A TRIAL PROCEDURE THE PATIENT HAD BLEEDING IN THE BANDAGE SITE AND THE DRESSING WAS SATURATED WITH BLOOD. IT WAS ALSO REPORTED THAT THE PATIENT WENT TO EMERGENCY ROOM (ER) DUE TO WEAKNESS, NUMBNESS IN LEGS AND LOSS OF BLADDER FUNCTION. THE PHYSICIAN BELIEVED THAT THE SYMPTOMS WERE NOT DEVICE RELATED. THE PATIENT UNDERWENT AN EARLY LEAD PULL AND WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181749 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7071057 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention