BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 8963163 · Received September 4, 2019

    Report

    Report Number
    3006630150-2019-04811
    Event Type
    Injury
    Date Received
    September 4, 2019
    Date of Event
    August 15, 2019
    Report Date
    September 4, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2317-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5032355, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50 CM. MODEL NUMBER/CATALOG NUMBER: SC-4316, BATCH/LOT NUMBER: 21891468, MODEL/CATALOG DESCRIPTION: CLIK ANCHOR. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING ABDOMINAL STIMULATION DUE TO THE PLACEMENT OF THE LEADS. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754874 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 20990310 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention