BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURX DIAPHRAGM PACING SYSTEM

    MDR report key: 13516211 · Received February 11, 2022

    Report

    Report Number
    3005868392-2022-00001
    Event Type
    Injury
    Date Received
    February 11, 2022
    Date of Event
    March 5, 2020
    Report Date
    February 12, 2022
    Manufacturer
    SYNAPSE BIOMEDICAL, INC.
    Product Code
    OIR
    PMA / PMN Number
    H070003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER CONTACTED THE PRESCRIBING PHYSICIAN/IMPLANTING SURGEON TO CONFIRM THE INCIDENT AND IDENTIFY THE DEVICE INVOLVED. THEY WERE AWARE OF THE EVENT BUT COULD NOT DETERMINE WHETHER OR NOT THE EVENT WAS INITIALLY CAUSED BY THE DEVICE. IN THEIR OPINION THE CASE REPORT DEMONSTRATED THAT, FOLLOWING CARDIAC ARREST, THE VENTRICLE WAS IRRITABLE. BUT THEY COULD NOT SAY WHETHER THE DEVICE DID OR DID NOT CAUSE THE CARDIAC ARREST. CARDIAC RHYTHM INTERFERENCE IS A KNOWN POTENTIAL RISK IDENTIFIED IN THE DEVICE LABELING. THE APPROPRIATE PROCEDURES DESCRIBED IN THE DEVICE LABELING WERE FOLLOWED TO ASSESS FOR CARDIAC INTEREFERENCE AT THE TIME OF SURGERY. THERE WERE NO REPORTS OF ANY TYPE OF CARDIAC INTERFERENCE (PVCS, ETC.) PRIOR TO THE ARREST. ADJUSTING THE DEVICE SETTINGS, AS DESCRIBED IN THE CASE REPORT, WAS THE CORRECT RESPONSE TO ADDRESS THE PROBLEM.

    Description of Event or Problem · 0

    THE DEVICE MANUFACTURER LEARNED OF AN ADVERSE EVENT FROM A PUBLISHED CASE REPORT DISCOVERED DURING A POST-MARKET LITERATURE REVIEW. THE EVENT IS DESCRIBED AS FOLLOWS IN THE CASE REPORT: "A (B)(6) PREVIOUSLY HEALTHY MAN INITIALLY PRESENTED TO AN OUTSIDE HOSPITAL WITH RAPIDLY PROGRESSIVE QUADRIPLEGIA, FOUND TO HAVE AN ACUTE SPINAL CORD INFARCTION SECONDARY TO FIBROCARTILAGINOUS EMBOLI FROM DISC MATERIAL, COMPLICATED BY RESPIRATORY FAILURE REQUIRING CHRONIC MECHANICAL VENTILATION. THE PATIENT UNDERWENT DIAPHRAGMATIC PACEMAKER SYSTEM (DPS) IMPLANTATION TO LIBERATE HIM FROM THE VENTILATOR WITH NO COMPLICATIONS. THE PACEMAKER VOLTAGE WAS UP-TITRATED WITH A STIMULUS AMPLITUDE OF 25MA AND PULSE WIDTH OF 200 MS OVER SEVERAL WEEKS AND THE PATIENT WAS DISCHARGED TO A LONG-TERM ACUTE CARE HOSPITAL. TWO MONTHS LATER, THE PATIENT DEVELOPED FREQUENT PREMATURE VENTRICULAR CONTRACTIONS (PVCS) ON TELEMETRY WHILE AFEBRILE, NORMOTENSIVE AND NOT HYPOXIC. THREE HOURS AFTERWARDS, HE DEVELOPED POLYMORPHIC VT FOLLOWED BY VF AND CARDIAC ARREST (FIGURE 1). RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED AFTER PROLONGED CARDIOPULMONARY RESUSCITATION BY ADVANCED CARDIAC LIFE SUPPORT ALGORITHM INCLUDING NUMEROUS SHOCKS. THE DPS WAS SUBSEQUENTLY TURNED OFF AND THE PATIENT WAS TRANSFERRED TO THE HOSPITAL. POTASSIUM AND MAGNESIUM WERE WITHIN NORMAL LIMITS, AND INITIAL LACTATE WAS 1.9MMOL/L. TROPONIN-I DOWN-TRENDED FROM 5.98 TO 5.51 NG/ML. DIPHENHYDRAMINE WAS THE ONLY POTENTIAL QT-PROLONGING MEDICATION THE PATIENT TOOK, BUT THERE WAS A NORMAL QT INTERVAL ON THE ADMISSION ELECTROCARDIOGRAM (EKG) TAKEN POST-ARREST (FIGURE 2), WHICH EXCLUDES DRUG-INDUCED QT PROLONGATION. OF NOTE, THERE WAS J-POINT ELEVATION IN PRECORDIAL LEADS SUGGESTIVE OF EARLY REPOLARIZATION, WHICH HAS BEEN ASSOCIATED WITH IDIOPATHIC VF.1 AN ECHOCARDIOGRAM WAS OBTAINED, WHICH SHOWED A LEFT VENTRICULAR EJECTION FRACTION (LVEF) OF 30% AND RIGHT VENTRICULAR SYSTOLIC PRESSURE OF 33.7MMHG. CORONARY CATHETERIZATION SHOWED NORMAL CORONARIES, AND COMPUTED TOMOGRAPHY (CT) OF THE HEAD AND CHEST SHOWED NO ACUTE PATHOLOGY. A REPEAT ECHOCARDIOGRAM WAS OBTAINED PRIOR TO DISCHARGE SHOWING FULL RECOVERY OF LVEF AND NO STRUCTURAL ABNORMALITIES. THE INITIAL ECHOCARDIOGRAM WAS THOUGHT TO REPRESENT STUNNED MYOCARDIUM IN THE SETTING OF RESUSCITATED CARDIAC ARREST AS EVIDENCED BY NORMALIZATION OF LVEF AND OVERALL CLINICAL TIME COURSE. AN INITIAL TRIAL OF MANIPULATION OF THE DPS AT LOW VOLTAGE WAS UNABLE TO PROVOKE VT (FIGURE 3). GIVEN THE INITIALLY UNCLEAR AETIOLOGY OF VT AND THE PATIENT'S YOUNG AGE AND GOOD PROGNOSIS, A SINGLE CHAMBER IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) WAS IMPLANTED. SUBSEQUENTLY, THE DPS VOLTAGE WAS INCREASED, RESULTING IN RECURRENT NONSUSTAINED VT ON TELEMETRY WHICH RESOLVED WHEN THE DPS WAS TURNED OFF. IT WAS RESTARTED AT A LOWER VOLTAGE WITH A STIMULUS AMPLITUDE OF 15MA AND PULSE WIDTH OF 130 MS ON THE LEFT SIDE RESULTING IN NO ECTOPY RECURRENCE. AN ICD INTERROGATION 1 MONTH AFTER DISCHARGE SHOWED NO EVIDENCE OF FURTHER ARRHYTHMIAS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106987 NEURX DIAPHRAGM PACING SYSTEM NEURX DPS OIR SYNAPSE BIOMEDICAL, INC. 20-0035 20-0035-100919-5-5

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Male Life Threatening