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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNK GENERATOR

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CYBERONICS PULSE GEN MODEL UNK GENERATOR Back to Search Results
Event Type  Malfunction  
Event Description

A publication titled ¿efficacy of neuromodulation therapy with vagus nerve stimulator in patients with drug-resistant epilepsy on unchanged antiepileptic medication regimen for 24 months following the implant¿ by chayasirisobhon et. Al. Was received which contained adverse events involving vns patients. The publication indicated that eleven patients were either non-responders to vns or had worsening of seizure frequency following implant. The authors noted that the patients¿ and the treating neurologists¿ desired to achieve a decreased dose and reduced number of aeds after vns implantation which may have caused or contributed to the event. It is unknown how many of the 11 patients were non-responders or how many experienced increased seizure frequency. Attempts for additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

Chayasirisobhon s, cahan l, choi sh, enos b, hwang j, et al. (2015) efficacy of neuromodulation therapy with vagus nerve stimulator in patients with drug-resistant epilepsy on unchanged antiepileptic medication regimen for 24 months following the implant. J neurol neurophysiol 6: 268. Doi:10. 4172/2155-9562. 1000268.

 
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Brand NamePULSE GEN MODEL UNK
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS
100 cyberonics blvd
houston TX 77058
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 Key4664751
Report Number1644487-2015-04391
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Literature,Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 03/17/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/07/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/17/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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