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

Model Number 103

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Death (1802); Seizures (2063)

Event Date 01/01/2015

Event Type  Death  

Event Description

It was reported that the patient passed away on (b)(6) 2015.It was reported that the cause of death has not been established but the nurse practitioner noted that it ¿may be related to epilepsy¿.The patient had been reported as having had increased seizures that day.The patient has been known not to take his medication and that nurse practitioner was told that the patient had not taken his medication for a couple of days.It was stated that when on medication, in conjunction with vns, the patient was seizure free.The nurse practitioner also stated that she does not feel that the patient¿s death is related to vns.The nurse practitioner later reported that the patient was found deceased by his father at home and was pronounced dead there.The nurse practitioner stated that the cause of death is not clear at this time.No autopsy was performed and the patient was cremated per his family¿s wishes.

Event Description

A mortuary called to return an explanted generator from a patient who passed away in 2015.No further information was provided.The generator has not been received for analysis to date.

Event Description

Product analysis for the generator was completed and approved.The pulse generator diagnostics were as expected for the programmed parameters.In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, 2.972 volts as measured during completion of the final electrical test, shows an ifi=no condition.The data in the diagaccum consumed memory locations revealed that 29.468% of the battery had been consumed.There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description

The patient's explanted lead and generator were received for analysis.Product analysis on the lead was completed and approved.A large portion of 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.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device.Note that since a large portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Product analysis for the generator is currently still underway.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• 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: 4473347
• MDR Text Key: 5503658
• Report Number: 1644487-2015-03721
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2014
• Device Model Number: 103
• Device Lot Number: 3516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/06/2015
• Initial Date FDA Received: 02/02/2015
• Supplement Dates Manufacturer Received: 11/08/2017; 12/11/2017; 01/10/2018
• Supplement Dates FDA Received: 11/29/2017; 01/05/2018; 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2013
• 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: 53 YR