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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 05/06/2013
Event Type  Malfunction  
Event Description

On (b)(6) 2013 it was reported that the vns patient was experiencing tightness and in her neck that started about two weeks ago. The nurse also stated that the patient has been experiencing an increase in seizures that started around the same time, two weeks ago. The device was interrogated on (b)(6) 2013 and the settings were output=0. 75ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=1ma/magnet on time=30sec/magnet pulse width=500usec. High impedance was observed on (b)(6) 2013 with output=limit/lead impedance=high/dcdc=7/eos = no. The patient¿s vns was disabled due to the high impedance. The nurse stated that almost immediately after the device was disabled, the tightness that the patient was experiencing improved. There has not been any recent trauma and the patient denied any device manipulation. X-rays were ordered and the patient was referred for surgery. It was reported that the patient previously was followed by a different physician but that physician has left the practice. The patient was last interrogated in (b)(6) 2012 and per the patient¿s chart, device diagnostics were not performed at that time. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The nurse later reported that the patient had also been experiencing voice changes during the same time as the tightness in the neck. She stated that they do not have a copy of the patient¿s x-rays but that the patient might have a copy that could be sent to us; she stated she would follow-up with the patient regarding this. No further information has been provided to date. Although surgery is likely, it has not occurred to date.

 
Event Description

On (b)(6) 2013 ap neck and chest and a lateral chest x-rays were received for review. The images were dated (b)(6) 2013. The generator was seen in normal orientation in the left chest area. The filter feedthru wires and lead at the connector pin appear intact. The lead pin could not be seen past the second connector block, indicating that it may not be fully inserted into the generator. A portion of the lead appeared to be present behind the generator. The electrodes were observed in the neck and appeared to be in proper alignment. Based on the x-ray images provided, the cause of the high impedance is unknown; however, it could be related to a possible lead pin insertion issue. The presence of additional micro-fractures in the lead also cannot be ruled out.

 
Event Description

On (b)(6) 2013 it was reported that the lead impedance after surgery was noted to be ¿ok¿. Attempts were made for the return of both the lead and generator but neither product has been returned for product analysis to date.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. The lead pin could not be seen past the second connector block, indicating that it may not be fully inserted into the generator.

 
Manufacturer Narrative

Follow-up report #1 should have stated that attempts were made for the return of both the lead and generator, instead of just the generator.

 
Event Description

On (b)(6) 2013 the nurse reported that pa and lateral chest x-rays have been performed and will be sent for review; however they have not been received by the manufacturer to date. The nurse also stated that around the time the patient started to notice voice changes and tightness with stimulation, her seizure frequency increased from 1-2 times per week to once per night. During this time the patient was also not sleeping well therefore it was unclear what was causing the increase in seizures. The surgeon noted that he suspects a malfunction of the vns as her chest x-ray revealed the vns to be in continuity. The patient underwent a full revision surgery on (b)(6) 2013. Attempts were made for the return of the explanted generator but it has not been received by the manufacturer.

 
Event Description

On october 3, 2013, the manufacturer received a letter from the food and drug administration (fda) providing a report from the fda's medwatch program. Based on the nature and timing of the reported pain, dyspnea, and muscle spasms, it is possible that the event is related to the high impedance event. Below is the quoted event description from the medwatch report (mw5031542): "volun 27-aug-2013: i had a vagal nerve stimulator implanted on (b)(6) 2010 at a hospital. The vns was to control irretraceable seizures from juvenile myoclonic epilepsy. From the time the vns was turned on, i experienced severe tightening of my throat, extreme hoarseness (usually laryngitis for several days after the vns was adjusted,) and stinging pain in my throat every time the device was sending electrical currents (approximately every 2 minutes). Beginning in (b)(6) 2013, my neck began to cramp when the vns would send the current and my seizures became more and more frequent. During the weekend of (b)(6) 2013, the side effects became so severe that i was having trouble breathing. My throat felt like it was closing up. During my routine neurologist visit on (b)(6), it was determined through diagnostic testing that my vagus nerve was not receiving any of the electrical stimulation the vns was sending out. The vns was immediately turned off and after an appointment with my neurosurgeon, i had revision surgery on (b)(6) 2013. ".

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key3167236
Report Number1644487-2013-01765
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/21/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/13/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2014
Device MODEL Number302-20
Device LOT Number2542
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/03/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/14/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/13/2013 Patient Sequence Number: 1
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