BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEURX DIAPHRAGM PACING SYSTEM

    MDR report key: 3528180 · Received December 12, 2013

    Report

    Report Number
    3005868392-2013-00004
    Event Type
    Other
    Date Received
    December 12, 2013
    Date of Event
    September 24, 2013
    Report Date
    December 12, 2013
    Manufacturer
    SYNAPSE BIOMEDICAL INC.
    Product Code
    OIR
    PMA / PMN Number
    H100006
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER INDICATED THAT THE EVENT WAS NOT DEVICE-RELATED, BUT IT WAS HIGHLY PROBABLE THAT IS WAS RELATED TO THE IMPLANT PROCEDURE. THE PT WAS SUBSEQUENTLY DISCHARGED, BUT THE DISCHARGE DATE IS UNK.

    Description of Event or Problem · 1

    PT HAD THE DEVICE IMPLANTED (B)(6) 2013 AND EXPERIENCED POST-OPERATIVE LEFT PLEURAL EFFUSION AND INFECTION CAUSING TACHYPNEA AND HYPOXEMIA. HE WAS TREATED WITH BIPAP, O2 AND ANTIBIOTICS. THERE WAS NO DROP IN HEMATOCRIT AND NO CHEST TUBE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651315 NEURX DIAPHRAGM PACING SYSTEM OIR DIAPHRAGMATIC/PHRENIC NERVE LAPAROS OIR SYNAPSE BIOMEDICAL INC. 20-0045 20-0045-112912-10-7

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization