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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105; GENERATOR
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LIVANOVA USA, INC. 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 Seizures (2063); Convulsion, Clonic (2222)
Event Date 10/01/2020
Event Type  malfunction  
Event Description
Patient presented with an increase in seizures.No other relevant information has been received to date.
 
Manufacturer Narrative
B5 describe event or problem , corrected data: initial report inadvertently left out data.F10 adverse event problem , corrected data: initial report inadvertently left out an adverse event code.
 
Event Description
It was reported that the patient had been experiencing a lot of new seizures and different types of seizures that she has not had for years.A worsening of seizures was also noted.
 
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Brand Name
PULSE GEN MODEL 105
Type of Device
GENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
MDR Report Key11285383
MDR Text Key230615477
Report Number1644487-2021-00177
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750054
UDI-Public05425025750054
Combination Product (y/n)N
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 03/03/2021
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 Date07/12/2019
Device Model Number105
Device Lot Number5504
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 01/15/2021
Initial Date FDA Received02/05/2021
Supplement Dates Manufacturer Received03/03/2021
Supplement Dates FDA Received03/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age18 YR
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