• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LIVANOVA USA, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problems Corroded (1131); Fracture (1260); Device Contamination with Body Fluid (2317)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2018
Event Type  malfunction  
Event Description
It was reported from an implant received that a patient had a full vns replacement due to high impedance.Device history record was reviewed for the lead.The lead passed all specifications prior to distribution into the field.Additional details indicated that the neurologist identified high impedance in an adjustment and referred it to the neurosurgeon.In the same week, a new vns kit was requested to be carried out to review the system, and the physician opted for the complete replacement of the equipment.Electrode returned with silicone rupture and physician opted for full exchange since the battery was near the end.The explanted device has not been received for analysis to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The lead was received for analysis.Analysis is underway but has not been completed to date.No additional or relevant information has been received to date.
 
Event Description
Product analysis for the lead was completed and approved.Abraded openings were noted in the outer and the inner silicone tubing.The reported fracture of leads was verified by product analysis.A break was identified in the positive coil.Scanning electron microscopy images show that pitting or electro etching conditions occurred at the break location.Appearance of the positive quadfilar coil broken mate end suggests a stress-induced fracture (fatigue) occurred in at least three strands.Since a portion of the lead (including the electrode array portion) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
rachel kohn
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key8399775
MDR Text Key138113601
Report Number1644487-2019-00432
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750139
UDI-Public05425025750139
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 05/16/2019
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 Date02/15/2020
Device Model Number304-20
Device Lot Number203705
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2019
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 02/12/2019
Initial Date FDA Received03/07/2019
Supplement Dates Manufacturer Received03/26/2019
04/19/2019
04/22/2019
Supplement Dates FDA Received04/18/2019
04/19/2019
05/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/18/2016
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 Age12 YR
-
-