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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 Convulsion, Clonic (2222)
Event Date 08/01/2021
Event Type  Injury  
Event Description
It was reported that the patient has experienced an increase in seizures since august.The patient's battery status was found to be 11-25% so they were referred for a battery replacement.Patient underwent generator replacement surgery.The explanted generator has not been received by product analysis to date.No other 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
dana sprague
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key13118129
MDR Text Key282965005
Report Number1644487-2021-01847
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 12/30/2021
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 Date04/13/2018
Device Model Number106
Device Lot Number203771
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 12/06/2021
Initial Date FDA Received12/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/27/2016
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) Required Intervention;
Patient Age20 YR
Patient SexMale
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