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Model Number 106
Event Date 12/22/2015
Event Type  Malfunction  
Manufacturer Narrative


Event Description

It was initially reported by the by the patient that she was having painful stimulation and increase in seizures, dysphagia, and coughing. It was noted by the physician's office that the patient's increase in seizures were not above pre-vns baseline levels and that simple vns setting adjustments resolved the issues and were not considered as serious injuries. However, the patient called again reported painful stimulation, voice alteration, and the inability to turn vns settings up. Additionally, the patient stated she has a feeling of being hungover for 72 hours after every settings change, which is described as a post-ictal state, including symptoms of blurred vision, headaches, very tired and lethargic. Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was later reported by the physician's assistant that they started the titration really slow, but the patient is still having these dramatic reactions and always coughs every time the device is titrated, but the patient states she wants to continue programming the settings up. The patient is determined to get up to 1. 5ma because she knows these are getting into the therapeutic level, but the patient is currently still at 1. 0ma. The patient's seizures are noted to be about the same as pre-vns baseline levels and the patient is also on multiple medications and medical marijuana. It was noted that some of these issues may be in the patient's head. It was noted system diagnostics are always checked and the device is performing as expected. It was also explained that the patient has these same types of reactions with medication changes, too. It was confirmed the patient has not had any serious injuries and the only interventions which have been taken are setting changes.

Event Description

An additional report was received that the patient's device was explanted. The reason for explant was stated to be the adverse events the patient was experiencing which included migraines, eye twitching, pain from the generator, and heaviness on her ribs. The physician stated the patient could not be titrated up fully as the patient experienced the adverse events when the output current was increased. The patient again reported feeling the "hangover" like symptoms and having an increase in seizures prior to the vns explant surgery. She also stated the vns device never worked for her. Diagnostics were performed and no issues were found and the diagnostics were within normal limits. The surgeon relayed the explant of the generator was for patient comfort and the lead was left implanted. The generator has not been received for analysis to date.

Event Description

The generator was received and product analysis was completed. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the device performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

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Type of DeviceGENERATOR
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key5889627
Report Number1644487-2016-01873
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup,Followup
Report Date 03/05/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/19/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/15/2017
Device MODEL Number106
Device LOT Number4587
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/08/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/08/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/27/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial