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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL UNK; GENERATOR
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CYBERONICS, INC. PULSE GEN MODEL UNK; GENERATOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 08/18/2014
Event Type  Injury  
Event Description
It was reported that the patient was hospitalized in status epileptics and was then placed into a medically induced coma.It was reported that the patient has tuberous sclerosis.If was later reported that the patient was still hospitalized in the intensive care unit.It was reported that it was decided not to turn the vns on until the patient is slabilized.The patient will undergo an mri.No additional relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL UNK
Type of Device
GENERATOR
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 Key4089982
MDR Text Key4746113
Report Number1644487-2014-02344
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2014
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
Date Manufacturer Received01/12/2015
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) Hospitalization; Required Intervention;
Patient Age11 YR
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