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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

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LIVANOVA USA, INC. 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 Convulsion, Clonic (2222)
Event Date 12/08/2021
Event Type  Injury  
Event Description
Patient presented with an increase in seizures and has been referred for a battery replacement.No known surgical intervention has occurred to date.No other relevant information has been received to date.
 
Event Description
Additional information received noting that the patient has been experiencing breakthrough seizures and it was noted that the vns has not providing the patient with the efficacy needed to normally function in society or at work.
 
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Brand Name
PULSE GEN MODEL 103
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 Key13117987
MDR Text Key282963538
Report Number1644487-2021-01846
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750030
UDI-Public05425025750030
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 01/31/2022
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 Date03/15/2021
Device Model Number103
Device Lot Number204875
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 12/08/2021
Initial Date FDA Received12/30/2021
Supplement Dates Manufacturer Received01/06/2022
Supplement Dates FDA Received01/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2019
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 Age30 YR
Patient SexFemale
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