MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2016

Event Type  malfunction  

Event Description

The patient reported that her physician communicated with her device, and it was already at 20% battery life only about 5 months after being implanted.The physician reduced the device settings, and he communicated to the patient that he was not concerned.The device history record of the device was reviewed, and the device performed according to specification prior to release.Attempts for further information were unsuccessful to date.

Event Description

Programming history was reviewed, and the diagnostics were within normal limits.However, the device was at 25% battery life after about 6 months of being implanted.The device was at relatively high settings, and there were many autostimulations since implant, which does deplete the battery.Longevity tables estimated around 3 yrs from beginning of life to ifi=yes.Therefore, it does appear that the battery was depleting more quickly than normal.No further relevant information has been received to date.

Manufacturer Narrative

Corrected data: follow-up report #1 inadvertently omitted the cause of the generator battery depleting prematurely.

Event Description

The cause of the premature battery depletion was most likely due to contaminates on the edge of the printed circuit board assembly (pcba), which caused a leakage path for current from the generator battery.This was due to the manufacturing method used on the generator.

Event Description

It was reported via clinic notes received that the patient's vns generator was at intensified follow-up indicator, or ifi, = yes condition.The physician lowered the patient's vns settings.It was reported that the patient was concerned as her vns did not last very long.

Event Description

It was reported that the patient underwent vns generator replacement surgery due to battery depletion as the generator was at a near end of service, or neos, condition.The explanted generator was received by the manufacturer and is pending product analysis.

Manufacturer Narrative

(b)(4).

Event Description

Generator product analysis was completed.The premature end of life indicator was confirmed in the product analysis, or pa, lab.During interrogation, the pulse disabled and end of service, or eos, warnings were observed.The pulse disabled byte would not reset.As such, diagnostics and the final electrical test, or fet, could not be performed.The vbat calculation was 1.947 v.The printed circuit board assembly, or pcba, was subjected to a postburn electrical test and the results showed the pcba failed several electrical tests.Fine grit sandpaper and isopropyl alcohol were used for removal of the observed contaminates from the trimmed edge of the pcba.The observed contamination suggested probable electrical paths were established between the copper edge on the trimmed edge, which contributed to the supply current conditions.The residual material on the pcba edge after test tab removal resulted in an increased current consumption for both standby and pulsing modes of operation, which is out of specification.

• Brand Name: PULSE GEN MODEL 106
• 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: 6204272
• MDR Text Key: 63261536
• Report Number: 1644487-2016-02945
• 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: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/20/2017
• Device Model Number: 106
• Device Lot Number: 203810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2016
• 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 Age: 38 YR