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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 01/01/2011
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 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 patient had a recent, apparent increased seizures, captured in manufacturer report number 1644487-2013-02100. The patient had previously sleep study that showed obstructive sleep apnea, but he was not considered a candidate for tracheostomy due to anesthetic risk. The obstructive sleep apnea was noted to possibly be contributing to his episodes of desaturation. Follow-up was performed with the treating physician who assumed care for the patient after initial implant. 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 "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. This report captures the patient¿s desaturation and sleep apnea. Manufacturer report number 1644487-2013-02100 captures the increased seizures and referral for generator replacement.

 
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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 Key3224902
Report Number1644487-2013-02099
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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