BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURX DIAPHRAGM PACING SYSTEM

    MDR report key: 7844352 · Received September 4, 2018

    Report

    Report Number
    3005868392-2018-00003
    Event Type
    Injury
    Date Received
    September 4, 2018
    Date of Event
    July 1, 2018
    Report Date
    September 4, 2018
    Manufacturer
    SYNAPSE BIOMEDICAL INC.
    Product Code
    OIR
    UDI-DI
    00852184003144
    PMA / PMN Number
    H070003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IS AN ACTIVE MILITARY MEMBER STATIONED IN (B)(6). HE HAD A "RED STREAK" FROM THE EXIT SITE OF HIS PERCUTANEOUS IMPLANT, WHICH RAN UP HIS CHEST AREA. HE WAS TREATED FOR AN INFECTION AT A MILITARY HOSPITAL IN (B)(6) WHERE HE WAS GIVEN ANTIBIOTICS. HE RETURNED TO (B)(6) AND THE INFECTION CONTINUED. HE CONTACTED HIS FOLLOWING PHYSICIAN AT THE UNIVERSITY OF (B)(6) WHERE HE LIVES AND WHERE HIS FOLLOW UP WAS BEING DONE (HE WAS IMPLANTED AT (B)(6) MEDICAL CENTER). HIS PHYSICIAN INSTRUCTED HIM TO STOP TAKING THE ANTIBIOTICS AND TO CALL HIM IF THE INFECTION CONTINUED. THE INFECTION DID NOT CLEAR UP AND THE PATIENT RETURNED TO UNIVERSITY OF (B)(6) WHERE HIS PHYSICIAN DECIDED TO REMOVE THE DEVICE. THE PATIENT WAS EXPLANTED SOME TIME IN (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685308 NEURX DIAPHRAGM PACING SYSTEM DIAPHRAGMATIC PACER OIR SYNAPSE BIOMEDICAL INC. 21-0017-99 21-0017-99-120716-40 00852184003144

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention