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Model Number 103
Event Date 09/13/2011
Event Type  Malfunction  
Event Description

It was reported that the patient came into the clinic recently and said that the vns is causing him severe voice alteration. It was confirmed that his voice was really hoarse such that he could barely speak. It was confirmed at the appointment that the device was turned off. The patient was told to see a throat specialist. This is an ongoing issue for the patient since 2013.

Event Description

The vns patient reported on (b)(6) 2013 that his device was turned off (b)(6) 2012 due to trigeminal neuralgia which was previously reported in mfg report number: 1644487-2004-00719. He reported since that time he has noticed that at times his voice changes randomly and he thinks his vns is still cycling at times. He says it occurs randomly. He also alleged that his vns sets off the anti-theft devices when he goes in and out of department stores. The patient then reported on (b)(6) 2013 that he had his device disabled about a year and a half ago. He again explained that he believes his device had turned itself back on as he has been experiencing hoarseness of voice and feeling the device cycling on and off since (b)(6) 2013. The patient explained that he does not feel the cycling all the time and that it only happens sometimes. When this does occur, the patient indicated that it can stimulate for a few hours up to a whole day. The patient firmly believes that an anti-theft device at a department store had spontaneously turned the device on. The patient has an appointment scheduled in (b)(6) 2013 with the currently treating physician. Follow-up with the physician's office on (b)(6) 2013 revealed that the patient had not reported these events to them. Review of the device history records for the vns generator revealed that all quality tests were passed prior to final release. Review of the patient's programming history revealed that on (b)(6) 2011 the patient's device was programmed off. The device was remained off on (b)(6) 2012. However, there is no subsequent programming history available after this date. In the (b)(6) 2012 notes when the patient was last seen, it was indicated that the patient believed his device had been turned off "due to solar flares" which the nurse was not sure what he meant by this. She is unsure if the device was actually turned off but they plan to check his vns device on his follow up appointment.

Event Description

On (b)(6) 2013, the patient reported that his vns has spontaneously started constantly cycling on again since (b)(6) 2013. Follow-up showed that the device was off. The patient was noted to have psychiatric co-morbidities. The physician did not recommend the device be removed at this time.

Manufacturer Narrative

Device history records were reviewed. Review of manufacturing records confirmed all quality tests were passed for the generator prior to distribution.

Event Description

The patient had an appointment at the neurologist's office on (b)(6) 2013. The device was interrogated and his device was confirmed to still be off. Although, it was noted that the patient complains of trigeminal pain but the device was confirmed to be off. (the trigeminal pain is captured in mfg report number: 1644487-2004-00719. ) the notes did not mention the patient reporting his vns setting off anti-theft devices or any adverse events associated with the vns believed to be on. It is unclear why the patient believed his device was on as the notes did not indicate the patient reported this but the nurse did indicate that this is not to say that the patient did not mention it at the visit. She further went on to state that it looks like the device was turned off in (b)(6) 2011 and then turned back on (b)(6) 2012. This past year it was officially turned off, but she did not provide the specific date upon request. The nurse did not have additional information.

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Type of DeviceGENERATOR
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058 770
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 Key2967448
Report Number1644487-2013-00447
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup,Followup
Report Date 01/23/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/19/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2012
Device MODEL Number103
Device LOT Number201513
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received01/06/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/07/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial