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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hiccups (1899); Convulsion, Clonic (2222); Cough (4457)
Event Date 03/08/2022
Event Type  Injury  
Event Description
The patient's mother reported that the patients vns battery is low and she is having increased coughing, hiccups, and seizures.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.
 
Manufacturer Narrative
B2.Corrected information, initial report: inadvertently did not select hospitalization.B5.Corrected information, initial report: inadvertently did not report the hospitalization due to seizures.F10.Corrected information, initial report: inadvertently did not use code f08 for hospitalization.
 
Event Description
The patients mom reported that the patient was hospitalized after having up to 20 seizures.The patients generator was replaced.The explanted generator has not been received to date.Information was received from the physician that the increase in seizures was back to pre-vns levels and was related to low battery.The coughing and hiccups were also believed to be due to low battery, and the replacement referral was for patient comfort only per the physician.No further relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL 106
Type of Device
GENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
LIVANOVA USA, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
dana sprague
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key13978484
MDR Text Key288396542
Report Number1644487-2022-00368
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 Other
Type of Report Initial,Followup
Report Date 04/29/2022
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 Date03/01/2019
Device Model Number106
Device Lot Number204067
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 03/08/2022
Initial Date FDA Received04/01/2022
Supplement Dates Manufacturer Received04/06/2022
Supplement Dates FDA Received04/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2017
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) Hospitalization; Required Intervention;
Patient Age25 YR
Patient SexFemale
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