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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 Insufficient Information (3190)
Patient Problem Seizures (2063)
Event Date 03/29/2014
Event Type  malfunction  
Event Description
The vns depression patient reported that she has experienced two seizures in the past four days.The patient reported that she has a seizure disorder.The patient indicated that she has not had the vns checked in a year.The patient was given the name of a vns physician to follow-up with; however, has not been seen by the physician to date.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 Key3784151
MDR Text Key4431288
Report Number1644487-2014-01156
Device Sequence Number1
Product Code MUZ
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 Consumer,Health Professional,Company Representative
Reporter Occupation Patient
Type of Report Initial
Report Date 04/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? No
Event Location Other
Initial Date Manufacturer Received 04/01/2014
Initial Date FDA Received05/01/2014
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 Age50 YR
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