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 05/03/2017

Event Type  malfunction  

Event Description

It was reported by the nurse practitioner (np) that the physician had interrogated the vns revealing the normal mode, magnet mode, and autostimulation output currents had been set to 0.0ma.The device showed eos (end of service) and was not supplying stimulation, which is a normal event once the device reached the eos condition.The np felt this was a malfunction since the device had only been implanted 2 years ago.The programming history for the generator was reviewed.No anomalies were noted, but it was confirmed the device had reached eos and that the output currents have been programmed off due to the eos condition.Impedance values were within normal limits indicating the device was working as intended.The device history record was reviewed and it was confirmed the generator had passed all required testing prior to distribution.It was confirmed the device was a laser routed device.Attempts for additional relevant information have been unsuccessful to date.

Event Description

The information in the programming history was decoded and reviewed.The vns diagnostics were within normal limits throughout the available data and it was noted the device had reached the eos = yes (end of service) condition.It was noted the voltage value was only 1.991v, consistent with an eos = yes condition; however, the percent battery consumed was only 19.768%.The information observed indicated the device depleted more quickly than expected.

Event Description

Information was received indicating the patient had been referred for vns generator replacement surgery due to the generator battery depletion.The vns generator replacement surgery has not occurred to date.

Event Description

No surgical intervention has occurred to date.No additional pertinent information has been received to date.

Event Description

Generator replacement surgery occurred and the device was received by the manufacturer.Analysis was completed for the returned generator.The septum was not cored.The reported premature end of life was duplicated.During the bench interrogation, the end-of-service warnings were set and the device was automatically disabled.The diagnostic battery voltage calculation confirmed an end-of-service condition.The downloaded data revealed that 20.215% of the battery had been consumed.Electrical testing showed that the device failed several electrical tests.Fine grit sandpaper was used for the removal of the observed contaminates from the trimmed edge of the printed circuit board assembly.Remaining residual material on the printed circuit board assembly edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption that was out of specification for both standby and pulsing modes of operation, and may have been the contributing factor for the premature end of life.

• 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: 6592911
• MDR Text Key: 76029400
• Report Number: 1644487-2017-03875
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/20/2017
• Device Model Number: 106
• Device Lot Number: 203439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/03/2017
• Initial Date FDA Received: 05/25/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/07/2017; 07/28/2017
• Supplement Dates FDA Received: 06/05/2017; 06/07/2017; 06/30/2017; 08/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2015
• 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: 35 YR