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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR
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LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dysphagia/ Odynophagia (1815); No Information (3190)
Event Date 08/28/2020
Event Type  Injury  
Event Description
It was reported that a patient had a "laryngeal side effect." this side effect resulted in disablement of the device.The patient was then referred for explant.It was reported that this explant was due to the device bothering the patient when active.No surgical intervention has occurred to date.No additional relevant information has been received to date.
 
Manufacturer Narrative
F10: patient event code: corrected data - dysphagia was added as the event term due to the side effect's description as laryngeal.
 
Event Description
It was reported that the patient's device was explanted.The suspect product has not been received to date.No additional information has been received to date.
 
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Brand Name
PULSE GEN MODEL 102
Type of Device
GENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
MDR Report Key10567198
MDR Text Key207933776
Report Number1644487-2020-01272
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,health
Type of Report Initial,Followup
Report Date 11/09/2020
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 Date06/30/2012
Device Model Number102
Device Lot Number2746
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 08/28/2020
Initial Date FDA Received09/22/2020
Supplement Dates Manufacturer Received10/15/2020
Supplement Dates FDA Received11/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age38 YR
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