MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101; GENERATOR

Model Number 101

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 07/02/2015

Event Type  Death  

Event Description

It was reported that a vns patient died.No information is available to date regarding the circumstances around the patient's death.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.The vns system was explanted postmortem.The explanted devices were received by the manufacturer; analysis of the devices is underway, but it has not been completed to date.

Event Description

An analysis was performed on the explanted generator, the device output signal was monitored for more than 24-hrs, while the 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.Analysis in the pa lab concluded proper functionality of the generator and that no abnormal performance or any other type of adverse condition was found.

Event Description

An analysis was performed on the returned lead portions.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 on the deposit observed on the unmarked connector boot and identified the deposit as containing silicon, phosphorus, sodium, magnesium, 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.Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device.Note that since 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.

Event Description

Review of available vns device programming history by the manufacturer indicates that the device was switched off on (b)(6) 2006.The explanted device was received by the manufacturer as programmed off and analysis showed the battery was not depleted.There is no evidence from the available information the device was ever turned on again and the patient was most likely not receiving vns therapy at the time of the death.

• Brand Name: PULSE GEN MODEL 101
• 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: 5406289
• MDR Text Key: 37333333
• Report Number: 1644487-2016-00217
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2004
• Device Model Number: 101
• Device Lot Number: 7812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 02/03/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/16/2016; 02/29/2016; 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2003
• 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: 64 YR