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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 105; GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 105; GENERATOR Back to Search Results
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Emotional Changes (1831); Cognitive Changes (2551)
Event Date 12/01/2018
Event Type  Injury  
Event Description
It was reported that the patient's mother wanted to have the patient's generator interrogated to confirm functionality.The mother indicated that she believed the generator was not working due to the patient being hospitalized due to cognitive impairment and mood swings.It was reported that the patient had a history of being manic and difficult to control and that the patient's neurologist had taken the patient off medications since their mood appeared better with vns, since seizures were being controlled.The patient's mother indicated that she believed the patient's vns was not working due to their mood swings not being controlled.No further relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL 105
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 Key8220129
MDR Text Key132194106
Report Number1644487-2019-00014
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750054
UDI-Public05425025750054
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 Other
Type of Report Initial
Report Date 01/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date09/01/2018
Device Model Number105
Device Lot Number203933
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 12/12/2018
Initial Date FDA Received01/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/06/2016
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;
Patient Age26 YR
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