BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 9391891 · Received November 29, 2019

    Report

    Report Number
    3006630150-2019-06930
    Event Type
    Injury
    Date Received
    November 29, 2019
    Date of Event
    November 10, 2019
    Report Date
    November 29, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2317-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5171098, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50 CM. MODEL NUMBER/CATALOG NUMBER: SC-1160, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 360581, MODEL/CATALOG DESCRIPTION: SPECTRA WAVEWRITER IPG KIT. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WAS FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A STAPHYLOCOCCUS INFECTION AT THE LEAD INCISION SITE. SYMPTOM OF INFECTION WAS PAIN AT THE LEAD SITE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NEITHER DEVICE RELATED NOR PROCEDURE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185217 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5167632 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention