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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

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LIVANOVA USA, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 05/30/2014
Event Type  Injury  
Event Description
It was reported that ever since initial implant, the patient experienced constant ear pain that was worse during stimulation.In the past, the physician tried reducing the settings but the pain did not resolve.The patient suspected the pain was related to the placement of the lead wire and desired a full revision surgery.The surgeon opted only to replace the generator, stating the cause of the pain in the ear could not be confirmed.It was recommended that the patient see the original surgeon who implanted the lead.It was also noted that the patient has allergies and recently was in a car accident, which may be related to the ear pain.Attempts for additional info have been made; no additional relevant info has been received to date.No further surgical intervention has occurred to date.
 
Event Description
Information was received indicating that the patient had been seen by an ent, who assessed that the lead may have been initially implanted too high on the vagus nerve, or that the electrode coils were not appropriately sized for the patient.The ent also recommended a lead repositioning surgery.No additional relevant information has been received to date.No known surgical intervention has occurred to date.
 
Event Description
The patient underwent lead revision surgery due to the reported ear pain.During the surgery, it was identified that there was inadequate strain relief on the lead and the strain relief was in the wrong location.The surgeon also noted that the electrodes were too high on the nerve, and the electrode diameter was too narrow for the patient's vagus nerve.The lead was replaced and was confirmed to have a better fit around the nerve.The explanted lead has not been received by the manufacturer to date.No additional relevant information has been received to date.
 
Event Description
Patient had full replacement due to jaw and ear pain.At first it was mostly during stimulation he said, but then it became constant.Immediately after the operation, the patient said he felt no more ear pain or jaw pain.
 
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Brand Name
LEAD MODEL 304
Type of Device
LEAD
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 Key11095624
MDR Text Key224382605
Report Number1644487-2020-01752
Device Sequence Number1
Product Code LYJ
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 Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 06/20/2022
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 Date12/05/2017
Device Model Number304-20
Device Lot Number3815
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 12/08/2020
Initial Date FDA Received12/30/2020
Supplement Dates Manufacturer Received12/30/2020
03/10/2021
05/26/2022
Supplement Dates FDA Received01/22/2021
04/02/2021
06/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/10/2013
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) Required Intervention;
Patient Age32 YR
Patient SexMale
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