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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 05/01/2014
Event Type  Injury  
Event Description

The patient had a follow-up appointment at which time the medications were adjusted, in addition to the magnet off time from 5 minutes to 3 minutes. Diagnostics were performed to check the device function and no anomalies were noted. The group staff was re-educated on magnet usage.

 
Event Description

The physician¿s office reported that after the patient was started back on medication, the patient has not been herself and had increased seizures. There are a lot of health issues. When the vns was checked previously, all diagnostics were okay.

 
Event Description

It was reported that the vns patient was experiencing an increase in seizures. The neurologist planned to give the patient new medication. Attempts for additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

 
Event Description

The nurse at the treating physician¿s office reported that they recently performed vns programming changes, but they have not worked. The vns is felt to not be working. She reported that the magnet did not work the morning of (b)(6) 2014 and resultantly the patient had a seizure. She said that they feel the magnet is not working, and the patient has also been having more seizures since may. The patient went about 6-8 weeks since december with only 4 seizures and now has increased to having seizures every couple of days, to every day and one day she had two seizures. The patient was actually admitted recently to the hospital due to cluster of seizures. They are trying to get her as controlled as possible and have gone through medication changes as well. It is unclear what the cause of the increased seizures is but the medical staff is wondering if the generator is nearing end of service. The relationship of the increased seizures to pre-vns seizure frequency level was unknown by the nurse. Cyberonics labeling indicates that vns magnet therapy is an adjunctive therapy and not all patients benefit from its use.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3916647
Report Number1644487-2014-01706
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/11/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/07/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2013
Device MODEL Number103
Device LOT Number3065
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/10/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/25/2011
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: 07/07/2014 Patient Sequence Number: 1
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