BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 9130959 · Received September 27, 2019

    Report

    Report Number
    3006630150-2019-05381
    Event Type
    Injury
    Date Received
    September 27, 2019
    Date of Event
    September 6, 2019
    Report Date
    September 27, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2316-50E, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5140881, MODEL/CATALOG DESCRIPTION: INFINION 16 TRIAL LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING NECK PAIN AND HEADACHES WITHER STIMULATION WAS ON OR OFF. THE PHYSICIAN SUSPECTS THAT THE PATIENT HAD A POST DURAL PUNCTURE WHICH WAS BELIEVE TO BE NOT DEVICE RELATED. THE PATIENT HAD A BLOOD PATCH AND UNDERWENT A LEAD PULL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924595 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 5132057 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention