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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
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Seizures (2063)
Event Date 12/21/2014
Event Type  Injury  
Event Description
It was reported that the patient was admitted to the hospital after experiencing five seizures.It was reported that the magnet stimulation was not aborting seizures and that the device was no longer helping the seizures as much.The patient believes that the vns is not working correctly.No additional relevant information was provided.Attempts to obtain additional relevant information have been unsuccessful to date.
 
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Brand Name
PULSE GEN MODEL UNK
Type of Device
GENERATOR
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 Key4427449
MDR Text Key5370156
Report Number1644487-2015-03647
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 12/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 12/21/2014
Initial Date FDA Received01/16/2015
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
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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