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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Seizures (2063)
Event Date 07/18/2008
Event Type  malfunction  
Event Description
Clinic notes indicated that a patient's mother reported that her son had experienced an increase in seizures since his vns was initially implanted.The vns settings were increased at a subsequent clinic visit 1 month after implant.The patient's mother reported that the seizures increased after the settings adjustment.A review of programming history available over the implant life of the patient's device indicated that the device functioned properly.No additional relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL 103
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 Key7144714
MDR Text Key95791860
Report Number1644487-2017-05080
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 company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 12/22/2017
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
Device Expiration Date03/31/2010
Device Model Number103
Device Lot Number200778
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 11/30/2017
Initial Date FDA Received12/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2008
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 Age10 YR
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