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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 Problems Paralysis (1997); Paresis (1998)
Event Date 03/17/2023
Event Type  Injury  
Manufacturer Narrative
Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.
 
Event Description
It was reported that the patient experienced extreme hoarseness after implant.It is noting that the patient's voice has gotten better but is still not the same as compared to before surgery.The patient had their device turned on and all values were within normal limits and there were no complaints received from the patient when the device was activated.The patient was later seen by an ent who reported that the patient's vocal cords were not functioning properly from the vns surgery.The patient will undergo a mri scan and then a plan will be devised to treat the patient afterwards.It was confirmed that the issue is with the patient's left vocal cord.The device history records for the lead were reviewed.The lead passed final functional and quality specifications prior to release for distribution.No other relevant information has been received to date.
 
Manufacturer Narrative
D5 operator of device, corrected data: initial report inadvertently did not select health professional.
 
Event Description
The patient was referred for a revision.The patient then underwent exploratory surgery and it was determined that the left vocal cord is not completely paralyzed.They conducted nerve testing and the vagus nerve is not severed nor is the recurrent laryngeal nerve.The generator and lead were not replaced but a system diagnostics was performed and the lead impedance was within normal limits.The ent is planning to provide vocal cord injections to treat the patient.
 
Event Description
Additional information received noting that the patient was recently seen in clinic and their voice is now fully restored.
 
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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 Key17332641
MDR Text Key319182098
Report Number1644487-2023-00942
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750139
UDI-Public05425025750139
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
Report Date 10/02/2023
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 Health Professional
Device Model Number304-20
Device Lot Number205953
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 06/22/2023
Initial Date FDA Received07/17/2023
Supplement Dates Manufacturer Received07/17/2023
09/07/2023
Supplement Dates FDA Received08/09/2023
10/02/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/06/2022
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) Disability;
Patient Age52 YR
Patient SexMale
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