MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 49728

Device Problem Reset Problem (3019)

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

Event Date 01/04/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that a generator resets the settings to zero when the normal mode diagnostic test is performed.It was reported that the generator also won't allow to do diagnostics unless there is an on time of at least 30 seconds.

Event Description

Additional information was received that some confusion was made with the initial report.The nurse corrected that they programmed the generator to 0ma because it was at end of service and put patient on the waiting list for replacement.It was reported that nurse's query to the manufacturer was about how long the device would last after the near end of service flag shows.It was reported that nurse did not feel the generator was not working; at the contrary, the patient is having good results from vns therapy and wants the generator to be replaced before the battery is totally depleted.It was reported that patient is worried from having seizures back because of interruption of vns therapy due to battery depletion.An estimation of the remaining life of the generator was performed by the manufacturer which confirmed the near end of service condition.

• Brand Name: PULSE GEN MODEL 102
• 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: 5390380
• MDR Text Key: 37233804
• Report Number: 1644487-2016-00144
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2016

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: 11/30/2009
• Device Model Number: 49728
• Device Lot Number: 200677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/04/2016
• Initial Date FDA Received: 01/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 34 YR