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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 03/05/2012
Event Type  Injury  
Event Description

On (b)(6) 2012, it was reported that this vns patient underwent surgery. During surgery, high impedance was seen. The high impedance report is captured in mfr report #1644487-2012-02047. The explanted generator was received on (b)(4) 2012 and is currently undergoing product analysis. On (b)(6) 2012, follow-up with the patient's physician was performed. The patient's device was last interrogated in (b)(6) 2011 and low battery was seen (one-quarter to one-third of battery life remaining). When the device was patient was seen for follow-up, it was noted that the battery was dead. The increase in seizures was attributed to the battery being dead. The physician believed the battery depleted very quickly from (b)(6) 2011 to (b)(6) 2012. The patient's device was turned on after surgery. The patient was seen post-operatively on (b)(6) 2012, with ok impedance at 3059 ohms. The patient was doing okay with modest seizure control, and the patient's settings were provided. It was stated that the settings would be gradually increased to their previous values. (the exact values were not provided. ).

 
Event Description

Clinic notes dated (b)(6) 2012 were received on (b)(6) 2012. These stated that the patient's vns generator recently reached end of life. The patient was having increased seizures. Recent lead tests showed that it was ok. The battery life was evaluated in (b)(6) 2011 with the reading indicating 18 months of remaining battery life. It was checked again in (b)(6), and the battery life still appeared sufficient. One month later (b)(6), the patients seizures activity increased, and the red light started flashing on the battery indicator. The patient's reported that the patient typically has between 2 and 40 seizures per day of brief duration. The seizures were described as drop seizures manifested by fluttering of eyelids, upper extremity laxity and gibberish speech. The seizures tend to occur in clusters. The patient had three seizures during the exam. The patient's eyes fluttered up and rhythmically beat, and there was behavioral arrest. The seizures lasted 30-45 seconds. During one seizure, the patient became quite limp during falling forwards. ; however, she immediately returned to baseline. Shortly after (b)(6) of the previous year, the patient began a ketogenic diet and the seizure frequency decreased. Additional clinic notes were received on (b)(6) 2012. Clinic notes dated (b)(6) 2012 described the patient's seizure semiology: the patient has brief drop seizures where her body will collapse down and the head flexes forward. Prior to the ketogenic diet, the patient had 40 to 50 seizures per day; however, at this time, she was having 6 to 15 per day. The patient also had tonic stiffening all over. These occurred 40 times per day pre-diet and 30 per day at this time. The patient also had spacing out seizures with the eye deviating upwards and outwards disconjugately. These may have been from one to 200 times daily, lasting five to 30 seconds. This frequency has stayed the same since the diet; however, they have become a new seizure type: the patient will speak and the speech will become unintelligible. The eyes will flicker, and the head drops. The patient tried to refocus but has difficulty with speech or her head will drop again. These last 90 to 120 seconds. Sometimes she will howl with these seizures. The patient had 15 of these in the last month. The patient's device was interrogated at this appointment. Clinic notes dated (b)(6) 2012 indicated that the reason for appointment was a history of rsv/ congestion. (it was also indicated that the patient had a cough for the past two days. ) clinic notes dated (b)(6) 2012 indicated that the patient's battery life was red. In (b)(6) 2011, the device was reported to have one-third of its life remaining. The patient's seizures had increased back to 30 per day. On (b)(6) 2012, additional programming and diagnostic history was provided from (b)(6) 2012 and (b)(6) 2012. Attempts for additional information have been unsuccessful. Surgery is likely, but has not occurred.

 
Event Description

Product analysis on the explanted generator was approved on (b)(6) 2012. Review of the data indicated that the pulsedisabled was set to a value that does represent a vbat

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2665729
Report Number1644487-2012-01850
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/25/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/23/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2010
Device MODEL Number103
Device LOT Number200981
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/21/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/11/2012
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/11/2008
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: 07/23/2012 Patient Sequence Number: 1
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