BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2939332 · Received February 1, 2013

    Report

    Report Number
    1644487-2013-00236
    Event Type
    Death
    Date Received
    February 1, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 5, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: PATIENT (B)(6) MALE WAS ENROLLED IN (B)(4), A RANDOMIZED, MULTI-SITE, OPEN-LABEL FEASIBILITY STUDY DESIGNED TO COLLECT DATA ON PATIENTS WITH STABLE SYMPTOMATIC HEART FAILURE ((B)(6) FUNCTIONAL CLASSIFICATION CLASS II/III) IMPLANTED WITH THE MODEL 103 AND MODEL 304 VNS THERAPY SYSTEM FROM BASELINE THROUGH 34 WEEKS POST-BASELINE. THE CLINICAL TRIAL IS BEING CONDUCTED IN (B)(6) AND HAS BEEN APPROVED BY (B)(6). THE VNS THERAPY PRODUCTS USED ARE THE SAME PRODUCTS USED IN COMMERCIAL DISTRIBUTION. THE PATIENT WAS RANDOMIZED TO CERVICAL VNS IMPLANTATION ON THE LEFT VAGAL NERVE. COMMON DEVICE NAME: PRODUCT CODE NKE (CONGESTIVE HEART FAILURE) IS AN UNAPPROVED INDICATION.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. THE RETURNED MODEL 103 GENERATOR PERFORMED WITHIN ALL SPECIFICATIONS DURING ELECTRICAL TESTING. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE GENERATOR. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO MANUFACTURER FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PROLONGED HOSPITALIZATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR IMPLANTATION OF THE DEVICE. PRE-SURGICAL CLINICAL FINDINGS INCLUDED PATIENT COMPLAINT OF MILD CHEST PAIN WITH DYSPNEA, LEFT SHOULDER PAIN, AND RIGHT LOWER LIMB PAIN AND NUMBNESS. THE PATIENT UNDERWENT GENERAL ANESTHESIA AND IMPLANTATION OF A LEFT VNS THERAPY SYSTEM ON (B)(6) 2013 WITH MODEL 103 GENERATOR SERIAL NUMBER (B)(4) AND MODEL 304-20 SERIAL NUMBER (B)(4) ON THE LEFT VAGAL NERVE. PER THE OPERATIVE NOTES, THE PATIENT'S NECK VESSELS WERE SEVERELY ENGORGED, BUT THERE WAS REPORTEDLY NO SEVERE BLEEDING DURING SURGERY. (OF NOTE, THE PATIENT WAS ON ANTI-PLATELET MEDICATIONS WHICH INHIBIT THROMBUS FORMATION). TWO NORMAL MODE DIAGNOSTIC TESTS WERE PERFORMED INTRA-OPERATIVELY PER LABELING WHICH WERE WITHIN NORMAL LIMITS. THE VNS SYSTEM WAS NOT PROGRAMMED ON, THAT IS THERE WAS NO STIMULATION, AT ANY OTHER TIME DURING OR AFTER THE IMPLANTATION PROCEDURE OF (B)(6) 2013. AFTER COMPLETING THE OPERATION ON (B)(6) 2013, THE PATIENT DID NOT REGAIN CONSCIOUSNESS AND WAS FOUND TO HAVE LATERALIZING NEUROLOGICAL SIGNS. AN INITIAL CT SCAN OF THE HEAD ON (B)(6) 2013 REVEALED A NON-HEMORRHAGIC LEFT FRONTO-TEMPERO-PARIETAL-OCCIPITAL INFARCTION AND EVIDENCE OF INTRA-CEREBRAL SWELLING. THE PATIENT WAS TREATED WITH ANTI-EDEMA MEASURES AND PULMONARY VENTILATION WAS CONTINUED POST-OPERATIVELY. TREATMENT INCLUDED IV DRUGS PIRACETAM, MANNITOL, CITICOLINE. HOWEVER, THE PATIENT'S NEUROLOGICAL CONDITION DETERIORATED. A SECOND CT SCAN OF THE HEAD ON (B)(6) 2013 REVEALED HEMORRHAGIC TRANSFORMATION OF THE LARGE INFARCT. IN RESPONSE TO THIS EVENT, THE PATIENT UNDERWENT NEUROSURGERY FOR DECOMPRESSION CRANIOTOMY OF INTRA-CEREBRAL SWELLING. AS OF (B)(6) 2013, THE PATIENT WAS PLACED ON A VENTILATOR AND WAS HAEMODYNAMICALLY STABLE WITH WORSENING RENAL FUNCTIONING. THE PATIENT WAS APPROPRIATELY MANAGED BY INTENSIVISTS, NEUROLOGISTS, NEUROSURGEON, AND CARDIOLOGIST. IN SPITE OF THE EFFORTS, THE PATIENT WAS DECLARED EXPIRED AND WAS REMOVED FROM THE VENTILATOR ON (B)(6) 2013. PER THE DEATH CERTIFICATE, THE CAUSE OF DEATH WAS ACUTE LEFT INTERNAL CAROTID ARTERY INFARCT WITH HAEMORRHAGIC TRANSFORMATION WITH CEREBRAL EDEMA AND DILATED CARDIOMYOPATHY, ACUTE RESPIRATORY FAILURE, PERIPHERAL VASCULAR DISEASE, TRICUSPID HEART DYSPLASIA, OLD ANTERIOR WALL MYOCARDIAL INFARCTION LEADING TO CARDIO-RESPIRATORY ARREST. IN THE OPINION OF THE INVESTIGATOR, THE RELATION OF THE DEATH TO THE IMPLANT PROCEDURE WAS DETERMINED TO BE PROBABLE; HOWEVER, THERE WERE CLINICAL FACTORS THAT LIKELY CONTRIBUTED TO THE DEATH. THE PATIENT HAD SIGNIFICANT CORONARY AND PERIPHERAL VASCULAR DISEASE THAT CONSISTED OF SEVERE, THREE-VESSEL CORONARY ARTERY DISEASE AND SEVERELY IMPAIRED LEFT VENTRICULAR SYSTOLIC FUNCTION, CAROTID ATHEROSCLEROSIS, BILATERAL CLAUDICATION WITH TOTAL INFRA-RENAL OCCLUSION OF THE AORTA. THE PATIENT ALSO HAD PRE-EXISTING SEVERE MITRAL REGURGITATION. THE OVERALL IMPRESSION OF THE CLINICAL EVENT ADJUDICATION COMMITTEE WAS THAT THE PATIENT WAS SEVERELY COMPROMISED AS A RESULT, WITH RISKS FACTORS FOR GENERAL ANESTHESIA COMPLICATIONS THAT INCLUDED PREVIOUS MYOCARDIAL INFARCTION, SEVERE ISCHEMIC CARDIOMYOPATHY, ONGOING HEART FAILURE, SEVERE MITRAL INSUFFICIENCY, TOTAL AORTIC OCCLUSION, AND RENAL INSUFFICIENCY, AND RISK FACTORS FOR THROMBOEMBOLISM THAT INCLUDED SEVERELY COMPROMISED LEFT VENTRICULAR FUNCTION INCLUDING LEFT VENTRICULAR DYSKINESIS, MITRAL INSUFFICIENCY, CAROTID ATHEROSCLEROSIS, AND RENAL INSUFFICIENCY. THE DEATH IS NOT BELIEVED TO BE RELATED TO VNS STIMULATION, AS THE DEVICE WAS NOT TURNED ON FOLLOWING IMPLANT. IMPLANTATION SURGERY HAS KNOWN POTENTIAL RISKS, COMPLICATIONS, AND SIDE EFFECTS IDENTIFIED IN BOTH THE INVESTIGATOR'S BROCHURE AND THE DEVICE LABELING. THE GENERATOR WAS EXPLANTED ON (B)(6) 2013. PRODUCT RETURN TO THE MANUFACTURER IS EXPECTED, BUT THE GENERATOR HAS NOT BEEN RECEIVED TO DATE. THE LEAD WAS NOT EXPLANTED PRIOR TO THE PATIENT'S CREMATION.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR WAS RECEIEVED BY THE MANUFACTURER FOR ANALYSIS. HOWEVER, PRODUCT ANALYSIS HAS NOT BEEN COMPLETED TO DATE. THE RETURN PRODUCT FORM INDICATED THE DEVICE WAS RETURNED DUE TO 'ACUTE ICA LEFT INFARCT WITH HEAMORRHAGIC TRANSFORMATION WITH CEREBRAL EDEMA LEADING TO DEATH.' EXPLANT DATE WAS ALSO LISTED AS (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44595 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 3305

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death| H INJ FOSPHENYTOIN| INJ RANTIDINE| MOISOL EYE DROPS| INJ FUROSEMIDE| INJ MANNITOL| INJ CEFOPERAZONE + SULBACTAM| K-BIND SACHET| INJ ONDANSETRON