BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 10463844 · Received August 28, 2020

    Report

    Report Number
    3006630150-2020-03750
    Event Type
    Injury
    Date Received
    August 28, 2020
    Date of Event
    July 22, 2020
    Report Date
    August 27, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT DEVICE: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 7070984.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE PATIENT EXPERIENCED HEADACHES DUE TO A DURA PUNCTURE. THERE WAS NO MEDICAL INTERVENTION PROVIDED HOWEVER THE PATIENT HAD AN EXTENDED HOSPITAL STAY. THE PATIENT IS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928847 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 3192710 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization