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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 06/27/2013
Event Type  Injury  
Event Description

It was initially reported by a medical professional that a vns patient who was a subject to a clinical study had presented adverse events: adverse event 1: cutaneous inflammation which started on (b)(6)-2013, ended on (b)(6)-2013. The event was not ongoing at the time of the report. The severity was indicated as moderate. Relationship to implant: definite. Not related to stimulation. Action taken: treatment withdrawn. Other action taken: surgery. Outcome: recovery/resolved. This adverse event caused the subject to discontinue the study. The adverse event was serious and it resulted in an initial or prolonged hospitalization. Adverse event 2: recurrent nerve palsy which started on (b)(6)-2013 and was still ongoing at the time of the report. The severity was indicated moderate. Relationship to implant: definite. Not related to stimulation. Action taken: n/a. Other action taken but not specified. Outcome: no recovery/not resolved. This adverse event did not cause the subject to discontinue from the study. The adverse event was serious and it resulted in a persistent or significant disability or incapacity. Further information was received indicating that there were no system diagnostics. The patient was admitted to (b)(4) hospital because of an inflammatory scar with redness and blistering without purulent fluid. No fever, no functional or general symptoms. Skin samples taken were negative. The day after the hospitalization, the scar opened by breaking of the blisters exposing the devices. It was decided to explant due to the risk of infection. The inflammation was at the level of scar. The left vocal cord was paralyzed during explant surgery. The patient was evaluated by an internal of the ear nose throat department, but no results of the exploration were sent to the manufacturer. Explant surgery had been performed on (b)(6)-2013. Resumption of two previous incisions was done. Inflammatory tissue, no purulent fluid found. Explant of the vagus nerve stimulator and electrodes was completed. Surgical cavities were washed and the edges of the scar resected. No general signs. The patient has intraoperative left recurrent laryngeal nerve palsy. Dysphagia to liquids with risk of aspiration. Normal solid diet. The surgical scar was clean and the patient was discharged on (b)(6)-2013.

 
Event Description

Additional information was received stating that the study patient¿s cutaneous inflammation was determined to be moderate device extrusion. The patient¿s recurrent nerve palsy was determined to be severe recurrent nerve paralysis which began on (b)(6) 2013. The patient was also experiencing moderate dysphagia on (b)(6) 2013 possibly due to vns implant and stimulation which also caused the patient to withdraw from treatment. The patient was recovering. The event was not considered serious.

 
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Brand NamePULSE GEN MODEL 102
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3521478
Report Number1644487-2013-03798
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/18/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/16/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number102
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received05/07/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 12/16/2013 Patient Sequence Number: 1
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