BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURX DIAPHRAGM PACING SYSTEM

    MDR report key: 2114661 · Received April 18, 2011

    Report

    Report Number
    3005868392-2011-00001
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    January 21, 2011
    Report Date
    April 15, 2011
    Manufacturer
    SYNAPSE BIOMEDICAL INC.
    Product Code
    HCC
    PMA / PMN Number
    H070003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE NEURX DPS WAS BEING USED "OFF-LABEL" WITH THIS PATIENT IN THAT THE PATIENT HAS A CARDIAC PACEMAKER, WHICH IS ADVISED AGAINST IN THE WARNINGS AND CAUTIONS AND PROCEDURE RISKS SECTIONS OF THE DEVICE LABELING (SURGEON INSTRUCTION MANUAL PN 77-0050 REV A). IN ADDITION, THIS PATIENT'S CARDIAC PACEMAKER WAS REPLACED AFTER THE NEURX DPS WAS IMPLANTED BUT THE PHYSICIAN WHO IMPLANTED THE NEURX DPS WAS NOT NOTIFIED AND THE PATIENT WAS NOT RE-EVALUATED FOR CARDIAC INTERFERENCE OR DEVICE TO DEVICE INTERACTION. SYNAPSE BIOMEDICAL IS AWARE OF ONLY FOUR INCIDENTS OF APPARENT DEVICE-INDUCED ARRYTHMIAS IN A POPULATION OF APPROXIMATELY 400 PATIENTS WITH THE DEVICE (B)(4). IN EACH OF THE FOUR CASES, THE PATIENT HAD A CARDIAC PACEMAKER IN PLACE AND ALL WERE MANAGED BY ADJUSTING STIMULUS PARAMETERS TO ELIMINATE ANY DETECTABLE INTERFERENCE. WE ARE AWARE OF APPROXIMATELY 25 PATIENTS WITH THE NEURX DPS THAT ALSO HAVE CARDIAC PACEMAKERS, TEN OF WHICH WERE IMPLANTED IN A CONTROLLED ARM OF THE (B)(4). BASED ON THIS INFORMATION, WE DO NOT BELIEVE ANY FURTHER ACTION IS NEEDED FOR PATIENTS (CURRENT OR PROSPECTIVE) WHO DO NOT HAVE CARDIAC PACEMAKERS. THE PRODUCT LABELING ALREADY WARNS AGAINST IMPLANTING THE DEVICE IN PATIENTS WITH CARDIAC PACEMAKERS BUT WE BELIEVE THE WARNINGS, CAUTIONS AND RISKS SHOULD BE ENHANCED GIVEN THE ADDITIONAL POST-MARKET CLINICAL INFORMATION AVAILABLE. SYNAPSE BIOMEDICAL WILL WORK WITH THE (B)(4) FOR THIS DEVICE VIA THE (B)(4) PROCESS TO STRENGTHEN THE LABELING.

    Description of Event or Problem · 1

    PER THE NOTIFYING PHYSICIAN, (B)(6), IN A LETTER TO THE IMPLANTING PHYSICIAN, (B)(6): THE PATIENT "WAS RECENTLY ADMITTED AT A LOCAL HOSPITAL IN (B)(6) WITH A DIAGNOSIS OF NEPHROLITHIASIS AND LEFT URETERAL STONE ON (B)(6) 2011. DURING HIS HOSPITALIZATION, HE HAD AN EPISODE OF VENTRICULAR FIBRILLATION AND CARDIAC ARREST REQUIRING CARDIOVERSION, DURING A BATHING PROCEDURE. HE WAS SEEN AND EVALUATED BY (B)(6), CARDIOLOGIST, WHO FELT THIS MAY BE DUE TO CONDUCTION OF DPS SYSTEM. DURING HIS HOSPITALIZATION, I SPOKE WITH (B)(6) AND ASKED TO HAVE THE PATIENT DISCONTINUE THE USE OF DPS SYSTEM, UNTIL WE HAD AN OPPORTUNITY TO EVALUATE THE SYSTEM IN AN ELECTROPHYSIOLOGY LAB. I MET THE PATIENT IN MY OFFICE ON (B)(6)2011 AND SCHEDULED HIM FOR EVALUATION IN OUR EP LAB WITH MY COLLEAGUE (B)(6), EP CARDIOLOGIST. ON (B)(6) 2011, WE EVALUATED THE PATIENT IN THE EP LAB AND WERE ABLE TO REPRODUCE EPISODES OF V-TACH WHILE USING THE DPS SYSTEM WITH CHANGES IN POSITION OF THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURX DIAPHRAGM PACING SYSTEM HCC SYNAPSE BIOMEDICAL INC. 20-0035 20-0035-080609-5-4

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention