BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEURX DIAPHRAGM PACING SYSTEM

    MDR report key: 3410448 · Received October 8, 2013

    Report

    Report Number
    3005868392-2013-00001
    Event Type
    Other
    Date Received
    October 8, 2013
    Date of Event
    May 10, 2013
    Report Date
    October 7, 2013
    Manufacturer
    SYNAPSE BIOMEDICAL INC.
    Product Code
    HCC
    PMA / PMN Number
    H070003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SYNAPSE BIOMEDICAL WAS NOT INFORMED THAT THIS PT HAD BEEN IMPLANTED UNTIL THE INITIATING INCIDENT WAS REPORTED APPROX ONE YEAR AFTER IMPLANTATION. IT WAS FIRST REPORTED THAT THE PT NEEDED A REPAIR AND REPLACEMENT OF ELECTRODE LEADS TO RELIEVE PAIN "IN HIS HEART" EXPERIENCED WITH STIMULATION. ASSISTANCE FROM SYNAPSE WAS REQUESTED FOR THE REPAIR PROCEDURE. OVER A PERIOD OF TWO MONTHS FOLLOWING THE PROCEDURE, SYNAPSE LEARNED THAT THE PT HAD RECEIVED AN INTERCOSTAL NERVE TRANSFER SOMETIME AROUND THE TIME THE SYNAPSE DEVICE WAS IMPLANTED. EVENTUALLY SYNAPSE ALSO LEARNED THAT, IN ADDITION TO PAIN, THE PT HAS EXPERIENCED VENTRICULAR TACHYCARDIA. BECAUSE OF THE RECENT (AT THE TIME OF DEVICE IMPLANTATION) NERVE TRANSFER THE DEVICE WAS NOT TESTED FOR A CARDIAC CAPTURE PER THE PROCEDURES IDENTIFIED IN THE SURGICAL INSTRUCTIONS FOR USE. THEREFORE, IT WENT UNDETECTED THAT SOME OF THE ELECTRODES WERE PLACED IN A POSITION THAT COULD CAUSE CARDIAC RHYTHM INTERFERENCE. THE IMPLANTING/REPORTING PHYSICIAN RECOGNIZES THAT, DUE TO THE UNUSUAL CIRCUMSTANCE OF A NERVE TRANSFER, THE TP WAS NOT PROPERLY TESTED ACCORDING TO PROCEDURES IDENTIFIED IN THE PRODUCT LABELING AT THE TIME OF DEVICE IMPLANTATION. THIS PHYSICIAN IS TRAINED AND EXPERIENCED IN USE OF THE DEVICE AND THE TESTING WAS NOT OVERLOOKED BUT COULD NOT BE PROPERLY PERFORMED DUE TO THE NERVE TRANSFER. HOWEVER, THE TESTING SHOULD HAVE BEEN PERFORMED LATER, PRIOR TO FIRST USE OF THE DEVICE. NO DEVICE DEFECT OR MALFUNCTION WAS INDICATED. DEVIATION FROM ESTABLISHED PROCEDURES DUE TO UNUSUAL CIRCUMSTANCES APPEAR TO BE THE SOLE CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH THE DEVICE SOMETIME AROUND (B)(6) 2012. THE PT ALSO RECEIVED AN INTERCOSTAL NERVE TRANSFER AND WAS UNABLE TO USE THE DEVICE UNTIL COMPLETE RECOVERY FROM THE TRANSFER, ABOUT MARCH OF 2013 THE PT BEGAN USING THE DEVICE FOR APPROX 8 HOURS PER DAY. ABOUT (B)(6) 2013, THE PT COMPLAINED OF FEELING THE DIAPHRAGM PACING "IN HIS HEART". THE PHYSICIAN HAS CONFIRMED THE PT DID NOT EXPERIENCE VTACH WITH STIMULATION FROM THE DEVICE. STIMULATION SETTINGS WERE REDUCED AND THE SYMPTOMS RESOLVED. ON (B)(6) 2013, THE PHYSICIAN SURGICALLY REPLACED THE ELECTRODE THAT WERE THE SOURCE OF THE STIMULATION ASSOCIATED WITH THE ARRYTHMIA. THE PT HAS RESUMED USING THE DEVICE WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509898 NEURX DIAPHRAGM PACING SYSTEM OIR DIAPHGRAGMATIC/PHRENIC NERVE LAPAROS HCC SYNAPSE BIOMEDICAL INC. 20-0035 20-0035-020912-7-1

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening| R