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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 Bronchitis (1752); Paralysis (1997)
Event Date 11/19/2023
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 livanovas 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 is experiencing vocal cord paralysis one week after operation.No other relevant information has been received to date.
 
Event Description
Additional information was received noting that the patient experienced vocal cord paralysis that is probably related to implant procedure is and recovering/resolving.More information was received noting that the patient is also experiencing bronchitis which is assessed to be probably related to implant procedure.Patient was noted to be hospitalized and added medication was done as intervention no other relevant information has been received to date.
 
Manufacturer Narrative
B3.Date of event; corrected data; initial mdr inadvertently reported incorrect date.B5.Describe event or problem; corrected data; initial mdr inadvertently omitted known information regarding the report of vocal cord paralysis.
 
Event Description
It was later reported that the bronchitis and vocal cord paralysis have recovered/resolved.
 
Event Description
During file review it was noted that supplemental aware date on supplemental 01 report should have been (b)(6)2024.
 
Manufacturer Narrative
B5.Describe event or problem; corrected data; supplemental 01 inadvertently provided incorrect aware date in g3.Date received by manufacturer (mo/day/yr).
 
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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
cindy scott
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key18345480
MDR Text Key330727606
Report Number1644487-2023-01802
Device Sequence Number1
Product Code MUZ
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 Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 03/29/2024
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 Number206054
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 11/23/2023
Initial Date FDA Received12/18/2023
Supplement Dates Manufacturer Received12/18/2023
03/06/2024
04/23/2024
Supplement Dates FDA Received02/02/2024
03/29/2024
04/23/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2023
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) Hospitalization; Disability;
Patient Age60 YR
Patient SexFemale
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