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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 08/01/2011
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2013 that the patient has an oxygen monitor shows oxygen levels drop several times a day which may lead to the patient turning blue. The patient¿s jerks are not necessarily associated with these episodes. The patient had a reduction in the tonic episodes and the oxygen drops at the last visit, but he has had a significant increase in (b)(6) 2011. The seizures range from 673-1477. There was noted to be no obvious etiology for the increase in seizures since the recent ear infection for which he was given a medication for ear infections. On (b)(6) 2013, the patient¿s seizures (myoclonic and tonic episodes and staring) were noted to range from 362 and 916. ¿he has been very agitated for about two weeks. ¿ the patient¿s medication appeared to be helping the patient except the previous month, per the caregiver. On (b)(6) 2013, he had been on a medication for ear infections for 10 days. On (b)(6) 2013, the physician noted that given the number medications and doses, no medication dosing changes were made. The physician¿s impression in the notes showed that it is unclear whether the seizures are primarily generalized tonic episodes or secondarily generalized seizures. Follow-up was performed with the treating physician who assumed care for the patient after initial implant. He reported that he does not believe the increased seizures were related to vns in 2011 or potentially 2013. He was unable to say if it occurred in 2013, but the patient's seizures have never been under good control. He actually believes the patient has a very bad seizure disorder, and the reason the seizure are "34;out of control"; is due to bad respiratory compromise. "in other words, he has tracheostomy and bad lungs, and he has a lot of times when his oxygenation goes down. A lot of his seizures are related to that rather than other else. " the physician has been trying to get the patient monitored to correlate the relationship of the seizures and desaturation, but the monitoring has not occurred to date. He believes the patient's seizures are mostly caused by the desaturation. The relationship between the desaturation and sleep apnea to vns is unknown because he needs to be monitored via sleep study to see if saturation improves when the vns is turned off. The onset of the sleep apnea/desaturation is unknown. Diagnostics on vns were okay as far as the physician knows. He reported that the caregiver reported they want the vns replaced so the physician agreed. The patient has not exhibited any other symptoms that may be related to vns. He did not know the relationship of the increased seizures to pre-vns seizure frequency. This report captures the patient¿s increased seizures since the relationship of sleep apnea/desaturation to vns is unknown to date. Manufacturer report number 1644487-2013-02099-2013-02100 captures the desaturation and sleep apnea. The patient had generator replacement in 2009. Although surgery is likely, it has not occurred to date.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3224901
Report Number1644487-2013-02100
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/18/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/12/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2011
Device MODEL Number103
Device LOT Number201114
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/18/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/10/2009
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: 07/12/2013 Patient Sequence Number: 1
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