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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 Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/25/2008
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that a vns patient would experience shortness of breath with exercise. The device was programmed off however the patient continued to experience shortness of breath and the patient was scheduled to have the device removed. The shortness of breath occurred sporadically and was not related to stimulation on times. Additional information received indicated that the patient suffers from anxiety and that was why the device was explanted. The anxiety is not related to vns and is pre-existing however the physician believed that due to the patient¿s anxiety, she could not handle being implanted with the device. The physician indicated that the shortness of breath could be related to the anxiety but was not sure. Additional information was provided that the device was explanted due to syncope and other complications. The explanting surgeon stated that at the time he noted that it was causing intermittent traction of the vagus nerve. It was noted that the patient also had increased heart rate. Clinic notes dated (b)(6) 2008 (a few months after implantation (b)(6) 2008), it was noted that since vns was implanted, before it was turned on, the patient has complained of shortness of breath and exercise intolerance (this may have been why the patient had increase in heart rate). There was a note that the patient did have exercise induced asthma prior to vns implantation. However, the patient states that it specifically causes problems with her breathing and believes it is all because of the vns. The notes then go on to state that vns was interrogated and settings were 0. 5ma (changed from 30sec on to 60sec). Notes indicated that the physician tested the patient¿s pulse oximetry and pulse before turning the vns on. There were no notable changes and the physician stated that based on the results the physician did not think there was any obvious change both with exertion and at rest whether or not the vns was on. The patient was still quite upset so they elected to turn it off. Notes dated (b)(6) 2009 indicate the device has still been off since (b)(6) 2008 and the patient still has had problems of a sense of pulling in her throat, difficulty breathing, exercise intolerance, syncopal episodes, left facial numbness, all of which she reports are intermittent. She can reproduce some of these problems when she turns her head to the right for prolonged periods of time or when she pushes upon the sternomastoid muscle a few cm from the incision. This would be at the location of the lead itself. The surgeon assessed the patient and attributed that there is excessive traction on the nerve with turning of her head and most of not all of her other symptoms are likely related to intermittent traction on the vagus nerve. Surgeon offered surgical intervention to possibly increase the size of the strain relief loop in an attempt to ameliorate the traction that she suspects caused these issues. He also offered a more extensive option to remove the vns if she preferred. The patient decided to remove the device entirely on (b)(6) 2009. The entire system was removed including all 3 helical coils. Notes dated (b)(6) 2009 did state that the patient has had none of the symptoms she had previously. No additional or relevant information has been received to date.

 
Manufacturer Narrative

Date received by manufacturer (mo/day/yr), corrected data. Supplemental mdr 31 inadvertently listed incorrect aware date, correct aware date is 03/23/2018.

 
Event Description

It was reported that the patient had too much scar tissue in the past from vns. No additional or relevant information has been received to date.

 
Event Description

Information was received that the patient did have re-implant surgery for vns therapy.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7237189
Report Number1644487-2018-00151
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 06/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/02/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2011
Device MODEL Number302-20
Device LOT Number200788
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/11/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/24/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/02/2018 Patient Sequence Number: 1
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