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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 10/04/2013
Event Type  Malfunction  
Event Description

On (b)(6) 2013 it was reported that the patient was seen by the physician that day and upon running diagnostics, high impedance (impedance value greater than 6200 ohms) was observed. This was when the patient was in the upright position. The physician had the patient lie down and ran diagnostics again, which showed the device was okay with impedance value of 3200 ohms. The patient was again re-positioned into an upright position. Diagnostics performed while the patient was in the upright position again showed high lead impedance with impedance value greater than 6200 ohms. It was confirmed that the patient had no trauma, no falls, and no manipulation. The patient went to have x-rays taken and it was stated that the vns device would be disabled to 0ma that day. Additional information was received that the patient's mother reports that the patient had an increase in seizures over the last two weeks, but not above baseline levels. The x-ray results indicated that there was no fracture. No other information has been provided.

 
Manufacturer Narrative

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

 
Event Description

Additional information was received stating that during an office visit on (b)(6) 2014, the vns patient¿s device was tested at several positions and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). The patient¿s device was subsequently programmed off. X-rays were taken and were reported by the physician to be unremarkable. No known surgical interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.

 
Event Description

Clinic notes were received for the vns patient office visits with his neurologist. Notes dated (b)(6) 2013 indicate that the patient had several breakthrough seizures since his last office visit with the most previous one occurring on (b)(6) 2013. The patient had one seizure at school consisting of generalized shaking of the extremities which appeared to slow or stop after magnet mode stimulation was activated. The patient's mother stated that the patient was having seizures throughout the night due to his drowsiness during the day. The patient continued to feel dizzy especially with physical activity. The patient had 2-3 head drops since his last office visit that occurred after having seizures while sleeping. The patient was able to feel when he was having a seizure and used the magnet frequently. The patient had different types of seizures over the past year: head drops lasting 10 seconds; generalized twitching of his extremities lasting 10-60 seconds; and clonic seizures lasting 15-30 seconds. The neurologist stated that overall the patient had an improvement sinc vns implant as the duration of his seizures had decreased significantly. The patient's device settings and medication was increased during the office visit. The neurologist stated that patient's wrestling with his siblings may have contributed to the high impedance observation. X-rays were taken during the office visit and were reported by the physician to be unremarkable. The patient's device was not disabled following the high impedance observation. Notes dated (b)(6) 2013 indicate that the patient had another seizure that lasted approximately one minute since his last office visit. The patient's device was tested during the office visit while the patient was sitting, lying, and turned his head. Diagnostic results from all the positions showed normal lead impedance. The neurologist stated that a microfracture may be a possible reason the high impedance observation at the previous office visit. Notes dated (b)(6) 2014 indicate that the patient had several seizures the week prior to his office visit. The patient's seizures were occurring at night. The patient's mother stated that the seizures would last approximately 10 seconds although she did not witness them. It was reported that magnet mode was activated but did not help in stopping the seizures. The patient's device had previously helped the patient reduce the duration of his seizures and postictal phase. The patient's medication was increased during the office visit. The patient's device was tested during the office visit and diagnostic results showed high lead impedance (impedance value >= 10,000 ohms). The patient's device was subsequently disabled. Notes dated (b)(6) 2014 indicate that the patient had three seizures in the past four weeks. The seizures were much milder and consisted of shaking of his entire body for 30-40 seconds. The patient also had 1-7 head drops that occurred throughout the day. The patient's device was tested during the office visit and diagnostic results showed high lead impedance. The patient's medication was increased during the office visit. Further follow-up revealed that the patient did not respond well to vns and the patient's seizures may be due to a combination of factors. X-rays were taken and were reported by the physician to be unremarkable. The x-rays will not be provided to the manufacturer for further review. The patient was seen prior to the his office visit in (b)(6) 2013 and diagnostics showed normal device function at the time. The patient was referred for replacement surgery but no known surgical interventions have occurred to date.

 
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Brand NameLEAD MODEL 304
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 Key3443991
Report Number1644487-2013-03381
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/04/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/01/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2017
Device MODEL Number304-20
Device LOT Number202378
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/25/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/24/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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