BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 9074006 · Received September 16, 2019

    Report

    Report Number
    3006630150-2019-05081
    Event Type
    Injury
    Date Received
    September 16, 2019
    Date of Event
    August 27, 2019
    Report Date
    September 16, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    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-2317-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5090008, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 70 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IT WAS ALSO NOTED THAT THE PATIENTS LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHEREIN THE CONNECTIONS BETWEEN THE LEADS AND BATTERY WERE LOOSENED AND THEN RECONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865613 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5090008 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention