BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURX DIAPHRAGM PACING SYSTEM

    MDR report key: 6682904 · Received June 30, 2017

    Report

    Report Number
    3005868392-2017-00001
    Event Type
    Injury
    Date Received
    June 30, 2017
    Date of Event
    April 19, 2017
    Report Date
    June 29, 2017
    Manufacturer
    SYNAPSE BIOMEDEICAL INC.
    Product Code
    OIR
    UDI-DI
    00852184003007
    PMA / PMN Number
    H070003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS NOTIFIED OF THE ADVERSE EVENT BY THE FDA. FDA PROVIDED INFORMATION FROM MEDWATCH REPORT MW5069531 TO SYNAPSE BIOMEDICAL VIA US MAIL, WHICH WAS RECEIVED BY THE MANUFACTURER ON MAY 30, 2017. THE CHIEF MEDICAL OFFICER FOR THE MANUFACTURER SUBSEQUENTLY CONTACTED THE PHYSICIAN TREATING THE PATIENT INVOLVED IN THE ADVERSE EVENT TO INVESTIGATE THE POTENTIAL INVOLVEMENT OF THE DEVICE IN THE EVENT. IT WAS NOTED THAT THE DEVICE WAS USED OFF-LABEL IN THIS CASE TO TREAT AN IDIOPATHIC DIAPHRAGM DYSFUNCTION. BOTH PHYSICIANS AGREED THAT, BECAUSE THE EVENT OCCURRED THREE WEEKS AFTER THE IMPLANTATION SURGERY, IT IS UNLIKELY THAT THE EVENT WAS RELATED TO THE SURGICAL PROCEDURE. TREATMENT OF THE PATIENT FOLLOWING THE EVENT INCLUDED A THORACOSCOPY WHERE THE TREATING PHYSICIAN WAS ABLE TO DETERMINE THAT THE IMPLANTED ELECTRODES WERE NOT (ABNORMALLY) PROTRUDING THROUGH THE DIAPHRAGM. BASED ON THE INFORMATION AVAILABLE IT DOES NOT APPEAR THERE WAS A DEVICE MALFUNCTION OR THAT THE DEVICE OR RELATED IMPLANTATION SURGICAL PROCEDURE CONTRIBUTED DIRECTLY TO THE EVENT.

    Description of Event or Problem · 1

    AS REPORTED BY THE MEDICAL FACILITY: PT ADMITTED DUE TO RIGHT HEMOTHORAX, LEFT SIDED CHEST PAIN EMESIS, ACUTE BLOOD LOSS ANEMIA AND HYPOTENSION. PT PRESENTED TO ER AFTER HAVING CHEST PAIN WORSE WITH INSPIRATION WHICH WAS SUDDEN ONSET WHILE IN THE SHOWER ON (B)(6) 2017 AT 9:15 AM. UPON ADMITTANCE PT STILL COMPLAINED OF CHEST PAIN AND HAD SEVERAL EPISODES OF EMESIS. CT PERFORMED IN ER SHOWING LARGE COMPRESSIVE LEFT COMPLEX FLUID COLLECTION. PHYSICIANS DRAINED THE FLUID VIA PIGTAIL AND SENT FLUID FOR ANALYSIS WHICH SHOWED NO GROWTH AFTER 5 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461178 NEURX DIAPHRAGM PACING SYSTEM NEURX DPS OIR SYNAPSE BIOMEDEICAL INC. 20-0035 20-0035-031017-4-2 00852184003007

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R