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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 Problems Dyspnea (1816); Paralysis (1997); Tissue Damage (2104)
Event Date 01/01/2016
Event Type  Injury  
Event Description
It was reported that the patient noted vns damaged her vocal cord.She stated that she could not breathe.She reported that the neurologist programmed vns off.No other additional relevant information has been received to date.
 
Event Description
The vocal cord damage was noted to have lasted about 3 months and then resolved and not damaged.The believed cause was vns stimulation.The damage was noted to be to the left vocal cord.
 
Manufacturer Narrative
1f0.Event problem cds , corrected data; initial mdr inadvertently submitted incorrect code.
 
Event Description
Additional information was noted from the neurologist that the vocal cord issue began in 2016.
 
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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
MDR Report Key11118702
MDR Text Key225142228
Report Number1644487-2021-00025
Device Sequence Number1
Product Code LYJ
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,Followup
Report Date 02/23/2021
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 Date03/25/2015
Device Model Number103
Device Lot Number202477
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 12/11/2020
Initial Date FDA Received01/05/2021
Supplement Dates Manufacturer Received01/08/2021
02/02/2021
Supplement Dates FDA Received02/02/2021
02/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age57 YR
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