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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

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LIVANOVA USA, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problems Fracture; Therapy Delivered to Incorrect Body Area
Event Date 11/21/2018
Event Type  Malfunction  
Event Description

The patient's neurologist reported that they interrogated the device because the patient was having some discomfort. Upon interrogation, high impedance was observed and the neurologist thought there could be a disconnection along the electrode and stated that ¿the device cannot transmit the proper stimulation to the patient¿s vagal nerve. " additional information was received that the patient has been referred for a revision. It was stated that the patient's discomfort is occurring in the neck area and is associated with stimulation. There was no trauma reported to that area, and the physician does not have an assessment of the cause of the patient's discomfort. No known surgical intervention has occurred to date. No other relevant information has been received to date.

 
Manufacturer Narrative

Event description, corrected data: initial report inadvertently did not indicate information from the received clinic notes. Patient code, corrected data: initial report inadvertently did not list an additional patient code.

 
Event Description

Clinic notes were received which indicated that the patient has been having slightly more seizures although it was stated to be subtle; the patient¿s mother suspects it is present. The vns device was interrogated and it was stated that high lead impedance was observed, which the doctor suspected would indicate a break in the line. It was also stated that there is evidence of sub-optimal control of the patient¿s seizures ever since she has felt discomfort in her neck. The neurologist believes there is an impedance break in her circuit from the stimulator cabling as a strong possibility to explain the behaviors of shock-like sensation. No other relevant information has been received to date. No known surgical intervention has occurred to date.

 
Event Description

It was reported that this patient received a full generator and lead replacement due to high impedance, and the explanted products were discarded after surgery. No further relevant information has been received to date.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
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 Key8146223
Report Number1644487-2018-02253
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/10/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/10/2008
Device MODEL Number302-20
Device LOT Number1169
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/06/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/08/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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