MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Device Expiration Issue (1216); Failure to Interrogate (1332); Unexpected Therapeutic Results (1631); Low Battery (2584)

Patient Problems Seizures (2063); Therapeutic Effects, Unexpected (2099)

Event Date 09/13/2016

Event Type  malfunction  

Event Description

A patient was being referred for generator replacement due to device end of service.The patient was also noted as having uncontrollable seizures since the device reached near end of service.Clinic notes were provided and the patient's mother stated that the device was "in the yellow".This is indicative of the device being at ifi - yes.The physician stated that he believed the depletion of the vns battery was the cause of the increased seizures.He also stated the increase in seizure frequency was > 50% from his baseline.The physician also reported that he was unable to interrogate the patient's device when seen on (b)(6) 2016.The physician's programming system had not been having any issues.Further follow-up was performed and it was unclear if the patient's device was interrogated.The generator was explanted on (b)(6) 2016.No further relevant information has been received to date.The explanted device has not been returned to the manufacturer to date.

Event Description

The explanted generator was returned to the manufacturer for analysis.The generator was able to be interrogated at a distance of one and one-quarter inches.The generator's output signal was monitored for an over 24-hour period while the generator was placed in a simulated body temperature environment where it verified its ability to provide the expected level of output current.A comprehensive electrical evaluation showed that the generator performed according to functional specifications.The battery voltage was measured at 2.523v, indicating a near end of service condition (neos = yes).The c4 capacitor on the generator was found out of specification, but this was component failure was not indicative of a device failure.

• Brand Name: PULSE GEN MODEL 103
• 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: 6024494
• MDR Text Key: 57320186
• Report Number: 1644487-2016-02342
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/13/2016

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: 05/18/2011
• Device Model Number: 103
• Device Lot Number: 2419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/13/2016
• Initial Date FDA Received: 10/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2009
• 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: 18 YR