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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102R; GENERATOR
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CYBERONICS INC PULSE GEN MODEL 102R; GENERATOR Back to Search Results
Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Seizures (2063)
Event Date 04/10/2015
Event Type  malfunction  
Event Description
It was reported that the vns patient was experiencing an increase in seizures.The patient¿s device was tested and diagnostic results showed normal device function.Attempts for additional relevant information have been unsuccessful to date.
 
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Brand Name
PULSE GEN MODEL 102R
Type of Device
GENERATOR
Manufacturer (Section D)
CYBERONICS INC
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 Key4746462
MDR Text Key5827501
Report Number1644487-2015-04610
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 04/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/31/2014
Device Model Number102R
Device Lot Number202332
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Date Manufacturer Received04/10/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2012
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 Age34 YR
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