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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 01/09/2012
Event Type  Injury  
Event Description

On (b)(6) 2012, a vns treating neurologist reported to the manufacturer's consultant that the vns patient was experiencing a 'tightness" in her neck and that over the weekend the patient's range of motion decreased and she could only turn her head about 10% in either direction. There is no pain with stimulation and the range of motion is independent of stimulation. Over the weekend, the patient also experienced a seizure and went to the emergency room. It took the patient a few days to recover. It was reported that the patient does not take her medications on a regular basis and she has a stressful lifestyle. On the friday before the weekend, (b)(6) 2012, the physician increased the patient's settings from an output of 1. 5ma to 1. 75ma. The patient remained in the office for 10-15 minutes following the programming change and reported that she was tolerating the increase. The patient was also observed on friday for her report that she had a clicking noise in her throat, however, no clicking occurred during the clinical visit and it lasted for 45 minutes. The patient reported that she had experienced two episodes of clicking in the front of her throat during stimulation. She stated that the clicking lasted for 30-60 seconds and the episodes were two weeks apart. There was no discomfort associated with this. The patient stated that the previous weekend, she also had a breakthrough seizure on (b)(6) 2012. The patient self-medicated with dilantin which elevated her dilantin level. Previously it had been six weeks since she had a seizure. The patient further stated that her husband is not using the recommended magnet swipe technique for her seizures. The husband was reported to be holding the magnet over the chest during the entire seizure, which disables stimulation, and then moved it away when the seizure stops. This then results in an uncomfortable strong stimulation after the seizure. Additional information has been requested but no further information has been received from the physician to date.

 
Event Description

Additional information was received on (b)(6) 2012 when the patient stated that her throat hurt with stimulation the night before but not as much in this morning. The patient said the magnet swipes help with seizures, but sometimes her husband swipes the magnet when she is coming out of a seizure and she can't tell him not to, and then it hurts. The patient was seen by the neurologist on (b)(6) 2012 and the vns device was interrogated and system diagnostics were performed which showed results within normal limits; lead impedance=ok/dcdc=2. The patient's generator was programmed to output=1. 5ma/frequency=30hz/pulse width=250usec/on time=7sec/off time=0. 3min/magnet output=2ma/magnet on time=60sec/magnet pulse width=250usec. During the final interrogation, the patient appeared to have an absence seizure then coughed and said she was having pain at the generator site. During the seizure, the magnet had been swiped. The generator was then programmed off, both in normal and magnet mode. The neurologist stated that he is going to leave the generator off until a 3 day video eeg can be done. On (b)(6) 2012, the patient reported that she is 2 days into the ambulatory monitoring and says she has had nocturnal seizures and migraines while monitored, but these are better tolerated without vns; she stated that vns gives her after effects like pain. The patient said she has discomfort above the generator randomly for 20-30 minutes at a time which is the same as before vns was turned off. The patient was seen for a follow-up visit on (b)(6) 2012 and the physician stated that he believes the patient's pain and "tightness" or limited range of movement, are psychiatric in nature and not related to vns. The physician turned the patient's device back on and the patient will not be seen again for another month.

 
Manufacturer Narrative

 
Event Description

The patient called and was crying and upset. Frustrated that she cannot tolerate the increases to her device. She is depressed because she has not been able to return to her former level of functioning prior to her re-implant last year. The patient's treating physician is aware of the patient's issues tolerating their stimulation and an appointment was going to be made for the patient to be seen for evaluation.

 
Event Description

Further reports regarding this patient's increased seizures with the suspect generator were received and all further relevant information regarding this event will be captured mfr. Report # 1644487-2017-03470.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key2461478
Report Number1644487-2012-00443
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/04/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2005
Device MODEL Number302-20
Device LOT Number008902
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/14/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/06/2003
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: 02/20/2012 Patient Sequence Number: 1
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