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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 05/10/2013
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2013 were received which provide the patient's seizure history. It was stated that the patient is still having seizures daily. The patient's last seizure was a grand mal seizure that lasted 2 minutes that day, and prior to this was the same type and length of seizure on (b)(6) 2013. The patient has continued with nocturnal events semiology of complex partial seizures per his baseline. He began having daily episode of quick head drops about one week prior to this date. His mother noted drainage from his left ear and had scheduled a follow up appointment to the ear nose throat doctor. It was noted that prior ear infections have been a trigger for the patient's epilepsy and mcad related hypoglycemia. Following a neuro metabolic consult, genetic testing confirmed the patient had mcad. Following the introduction of banzel, the patient became seizure free with associated improved cognition and psychomotor activation. Drop seizures returned in clusters with recurrent ear infections. They continued to increase in their daily frequency to greater than one hundred per day despite increasing doses of banzel and increased use of benzos. In addition, they were less responsive to use of the vns magnet. However, the notes also mention that the patient's mother was observed to be using the magnet incorrectly and was instructed on the correct use of the magnet during this office visit. The patient is experiencing nightime seizures which resolved with the addition of banzel; however, it was stated that it was unclear when they began to reoccur nightly. During the patient's last visit, the patient's lack of consciousness and multiple drop attacks of unclear etiology were noted resulting in patient hospitalization. During hospitalization, increased ammonia was noted. In addition, the patient was markedly responsive to iv, concluding that his presenting state was metabolic related. The patient's medication was increased and the eeg was conclusive for non-epileptic as well as epileptic events. At follow up, the patient's cognition was markedly improved over prior visits. In regards to the daily episodes of quick head drops that started a week prior, which had the semiology of non-epileptic events associated with hypoglycemia and increased metabolic needs. Attempts for additional information were made; however, they were unsuccessful. No additional information was provided.

 
Event Description

It was reported that the patient underwent generator replacement on (b)(6) 2013. The generator was returned for analysis on (b)(4) 2013. Analysis of the generator was completed on (b)(4) 2013. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 102
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3192841
Report Number1644487-2013-01947
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/28/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2008
Device MODEL Number102
Device LOT Number016318
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/12/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/10/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/05/2006
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: 06/27/2013 Patient Sequence Number: 1
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