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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR
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CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Seizures (2063)
Event Date 02/21/2018
Event Type  Injury  
Event Description
It was reported that the patient's seizures had increased in duration.The patient's neurologist doubted the vns to be causative as the device's settings are still being increased to therapeutic levels.No additional or relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL 106
Type of Device
GENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key7346089
MDR Text Key102704148
Report Number1644487-2018-00387
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750061
UDI-Public05425025750061
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 company representative,consum
Reporter Occupation Health Professional
Type of Report Initial
Report Date 03/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date06/27/2019
Device Model Number106
Device Lot Number5386
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Date Manufacturer Received02/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2017
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) Other;
Patient Age10 YR
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