MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Hemorrhage, Cerebral (1889)

Event Date 11/11/2014

Event Type  Death  

Event Description

It was reported that the vns patient passed away.The funeral home indicated that the patient passed away at home and no autopsy would be performed.The cause of death was noted to be intracerebral hemorrhage.The device was explanted and received for analysis.Analysis is underway, but has not been completed to date.

Event Description

Analysis of the lead was completed on 12/15/2014.Note that the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.What appeared to be white deposits were observed in various locations.Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, sulphur and calcium.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.Analysis of the generator was completed on 12/16/2014.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.

• Brand Name: PULSE GEN MODEL 104
• Type of Device: GENERATOR
• 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 Key: 4320656
• MDR Text Key: 5134950
• Report Number: 1644487-2014-03265
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2014
• Device Model Number: 104
• Device Lot Number: 202372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 39 YR