BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURX DIAPHRAGM PACING SYSTEM

    MDR report key: 14939989 · Received July 6, 2022

    Report

    Report Number
    3005868392-2022-00002
    Event Type
    Malfunction
    Date Received
    July 6, 2022
    Date of Event
    June 23, 2022
    Report Date
    July 6, 2022
    Manufacturer
    SYNAPSE BIOMEDICAL, INC.
    Product Code
    OIR
    UDI-DI
    00852184003212
    PMA / PMN Number
    H070003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THIS INCIDENT DID NOT RESULT IN SERIOUS PATIENT HARM, THE MANUFACTURER'S INVESTIGATION IDENTIFIED A DEFECT IN A DEFINED GROUP OF PRINTED CIRCUIT BOARDS (PCBS) THAT ARE A COMPONENT OF THE FINISHED DEVICE. SERIOUS HARM COULD RESULT IF ONE OF THE POTENTIAL FAILURE MODES OCCURS WITH ONE OF THE AFFECTED DEVICES. THE DEFECT WAS INTRODUCED AT A SUBCONTRACTOR THAT SUPPLIES THE PCBS AND A SUPPLIER CORRECTIVE ACTION HAS BEEN INITIATED. THE MANUFACTURER HAS INITIATED A RECALL OF AFFECTED FINISHED DEVICES AND A SEPARATE RECALL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 0

    THE PATIENT EXPERIENCED SEVERE PAIN ON THE LEFT SIDE OF THEIR DIAPHRAGM UPON INITIALIZATION OF STIMULATION WITH AN EXTERNAL PULSE GENERATOR. STIMULATION WAS REPEATED WITH A SECOND EXTERNAL PULSE GENERATOR AND THERE WAS NO DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422906 NEURX DIAPHRAGM PACING SYSTEM NEURX DPS OIR SYNAPSE BIOMEDICAL, INC. 23-0021 00852184003212

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other| R