BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 9418617 · Received December 5, 2019

    Report

    Report Number
    3006630150-2019-07106
    Event Type
    Injury
    Date Received
    December 5, 2019
    Date of Event
    November 19, 2019
    Report Date
    December 5, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2317-50. SERIAL NUMBER: (B)(4). BATCH/LOT NUMBER: 5131701. MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A WET TAP DURING THE IMPLANT PROCEDURE AND EXPERIENCED HEADACHE AFTERWARDS. THE PATIENT HAD A BLOOD PATCH DONE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212638 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5079689 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention