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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 01/07/2013
Event Type  Death  
Event Description

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.

 
Event Description

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.

 
Event Description

It was reported that the patient had prolonged hospitalization.

 
Manufacturer Narrative

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.

 
Event Description

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.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2939332
Report Number1644487-2013-00236
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/05/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/01/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2014
Device MODEL Number103
Device LOT Number3305
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/14/2013
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received05/27/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/10/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/01/2013 Patient Sequence Number: 1
Treatment
INJ FOSPHENYTOIN
INJ RANTIDINE
MOISOL EYE DROPS
INJ FUROSEMIDE
INJ MANNITOL
INJ CEFOPERAZONE + SULBACTAM
K-BIND SACHET
INJ ONDANSETRON
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