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

Model Number 101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Cancer (3262)

Event Date 05/19/2015

Event Type  Death  

Event Description

It was reported that the vns patient passed away on (b)(6) 2015.The cause of death and its relationship to vns are unknown.It was noted that the patient had cancer.The patient¿s device was not explanted; therefore, no analysis can be performed.Attempts for additional relevant information have been unsuccessful to date.Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be possible sudep. .

Event Description

The explanted generator and lead were received on (b)(4) 2016.Analysis was completed for the lead.Scanning electron microscopy images of the unmarked connector pin show appearance suggesting that pitting or electro-etching conditions have occurred on the pin surface.The exact reason for this condition is unknown.Since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.In the pa lab, the generator 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 of the device in the pa lab found that the eri flag was set.An open can measurement of the battery voltage confirmed that the eri flag had been properly set; the device was operating at low battery voltage.The low battery condition (depleted) was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation.The pa lab concluded proper functionality of the generator and that no abnormal performance or any other type of adverse condition was found.

• 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: 4871280
• MDR Text Key: 5860743
• Report Number: 1644487-2015-05027
• 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: Other,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2004
• Device Model Number: 101
• Device Lot Number: 7630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2003
• 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: 84 YR