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Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Pain (1994); Dizziness (2194)
Event Date 09/28/2018
Event Type  Injury  
Manufacturer Narrative


Event Description

It was reported from the patient¿s mother that her daughter had some serious adverse events over the weekend. She mentioned that the patient started feeling dizzy and nauseous and she had pain and muscle spasms on the left side of her neck. The mother tried to tape the magnet over the patient¿s generator but she stated that it seemed like the vns shocked the patient. The mother then took the patient to the er and was able to successfully tape the magnet over the patient's generator to mitigate the symptoms that the patient was experiencing. She stated they then went to her neurologist but the mother was upset because the neurologist completely ruled out the vns device and did not address their concerns. She did say that the settings were changed and she was informed that the battery was low, so the mother felt that the issue could be occurring due to the low battery of the patient's generator. The mother was asked if there was any recent trauma and she stated that the patient had about 4 seizures from friday to sunday and the patient usually falls down due to her seizures and "runs into things all the time. " it was also reported that the patient also had extreme voice alteration. The mother also alleged that the ¿device misfired and patient is in pain, the device is shocking her. ¿ she stated that her daughter is having dizziness, her heart rate will be up in the 120 or in the low 40s. She stated that she was seen in the er on monday and they said to tape the magnet on it. She then stated that her daughter is weak and tachycardic. The er gave her a beta blocker. They have tried taping the magnet on it, but her chest is getting really hot. There were also changes in her voice. They had never had a problem with the vns before. The mother also alleged complaints of nausea and vomiting. The patient then stated she felt better when the vns was placed over the generator. The patient then said it was getting hot. So uncomfortable that she won¿t go to sleep. The father then said it was comfortable for 10-20 minutes and then goes vibrating and goes into legs and stomach. It also shocks all the way over to the left side of her chest. She stated that she felt bad enough to call the ambulance herself (herself being the patient). The patient was referred for replacement. Notes indicated the same allegations as previously mentioned including, that the patient reports electric shock sensation from the device to patient's neck and whole body, chest pain, magnet held in place over the device after going to the er, magnet made the device feel hot to the patient. Patient reports voice hoarseness of voice twitching on left side of the face, and headache all of which the family thinks is related to vns. The physician states recently she has been having more seizures. She is also having problems with the current device including feeling electric sharp like sensation in her chest and myoclonic movements in her neck and he is recommending a change in the vns device. The physician is recommending prophylactic vns device change so that the patient can have auto stimulation to help reduce her seizures specifically the electric shock-like sensation she is feeling and the cluster of seizures she is having. No surgery has occurred to date. No additional or relevant information has been received to date.

Event Description

The patient underwent generator replacement surgery. The explanting facility is a no return site and discards the devices. No additional or relevant information has been received to date.

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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
njemile crawley
100 cyberonics blvd
suite 600
houston, TX 77058
MDR Report Key8004870
MDR Text Key124991374
Report Number1644487-2018-01912
Device Sequence Number1
Product Code LYJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/11/2016
Device MODEL Number103
Device LOT Number203085
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/31/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/13/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 10/25/2018 Patient Sequence Number: 1