MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problem Seizures (2063)

Event Date 05/10/2017

Event Type  malfunction  

Event Description

It was reported that a patient was experiencing an increase in seizure frequency and intensity.The patient was seen in clinic a week after this increase in seizures and the patient's generator had reportedly been disabled due to the generator reaching end of service (eos - yes).A battery life estimation showed that the generator was expected to have more battery life remaining.The patient was then programmed on during this office visit, but when the patient went back home she felt the device turn itself back off.The patient underwent a generator replacement surgery due to the generator being at end of service.A review of the available programming history showed indications of proper device functionality and diagnostics within normal limits.A review of the device history record showed that the device had passed all quality inspections prior to its release for distribution.

Event Description

Data from the generator was received and analyzed.It revealed that the battery voltage was lower than expected for the remaining battery capacity, indicating premature battery depletion.A review of the device history record showed the generator had been laser routed and sent out for distribution.The laser-routing process used in manufacturing of this generator is known to potentially cause conductive debris which cause excess current draw.No further relevant information has been received.

• Brand Name: PULSE GEN MODEL 105
• 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: 6629991
• MDR Text Key: 77347535
• Report Number: 1644487-2017-03947
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2017
• Device Model Number: 105
• Device Lot Number: 203402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2015
• 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: 48 YR