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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 Problems Low impedance (2285); Device Contamination with Body Fluid (2317)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/28/2019
Event Type  malfunction  
Event Description
It was reported that the patient had low impedance.The patient had x-rays taken and there were no visible fractures per the radiologist.The x-rays have not been received by livanova.Surgery is likely but has not occurred to date.No additional or relevant information has been received to date.
 
Manufacturer Narrative
Relevant test/laboratory data; corrected data: initial mdr inadvertently did not report settings and diagnostics.
 
Manufacturer Narrative
Describe event or problem, corrected data: follow-up report #02 inadvertently left out "a review of device history records revealed that the lead passed quality control inspection prior to distribution.".
 
Event Description
A review of device history records revealed that the lead passed quality control inspection prior to distribution.
 
Event Description
The patient underwent full vns replacement surgery.The surgeon first replaced the vns generator and tested the impedance.The low impedance did not resolve.After the full revision, all diagnostics were within normal limits.The surgeon noted fractures and fluid incursion into the lead tubing.The explanted products have not been received by the manufacturer to date.
 
Manufacturer Narrative
Section d.Suspect medical device; corrected information; incorrect device information (model, lot#, expiration date, manufacture date) inadvertently submitted on supplemental mdrs.
 
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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 Key8426044
MDR Text Key138971600
Report Number1644487-2019-00500
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,Followup
Report Date 03/11/2022
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 Date10/02/2015
Device Model Number304-20
Device Lot Number201893
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 02/28/2019
Initial Date FDA Received03/15/2019
Supplement Dates Manufacturer Received03/18/2019
04/02/2019
05/08/2019
05/20/2019
03/11/2022
Supplement Dates FDA Received03/18/2019
04/24/2019
05/08/2019
06/13/2019
03/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/03/2011
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 Age17 YR
Patient SexFemale
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