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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

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CYBERONICS - HOUSTON LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/03/2023
Event Type  malfunction  
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
Fda complaint forms were received for mdr report #: mw5146564 and mw5146565 indicating that the patients generator and lead were sent to directly to the fda with no allegation/complaints alleged on them.The lead form does however indicate there is a health effect - clinical code of: failure of implant on the lead.Device history records were reviewed.The device passed all functional and quality testing and was hp sterilized prior to distribution.The explanted device has not been received to date.No other relevant information has been received to date.
 
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Brand Name
LEAD MODEL 304
Type of Device
LEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
cindy scott
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key18163058
MDR Text Key328511501
Report Number1644487-2023-01662
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 Other,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/06/2021
Device Model Number304-20
Device Lot Number5359
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 10/25/2023
Initial Date FDA Received11/17/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/18/2017
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 Age65 YR
Patient SexMale
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