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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL UNK; GENERATOR
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LIVANOVA USA, INC. PULSE GEN MODEL UNK; GENERATOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Pain (1994); Visual Disturbances (2140)
Event Date 10/02/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient is experiencing left eye swelling, which can be weepy and irritating for the patient.It was noted that the swollenness tends to be worse after a seizure and the patient is now sensitive to light.It was also noted that opticians indicated that her vision in the left eye has declined.The patient has received 3 courses of antibiotic drops which have not helped.No surgical intervention has been reported to date.No additional relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL UNK
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
rachel kohn
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key10949986
MDR Text Key219863086
Report Number1644487-2020-01629
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Date Manufacturer Received11/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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; Required Intervention;
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