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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 303

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LIVANOVA USA, INC. LEAD MODEL 303 Back to Search Results
Model Number 303-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/02/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that a neurologist reported that he visibly could see and feel stimulation on a patient¿s neck. The neck was seen to be vibrating. Diagnostics were ok. The neck would vibrate a couple times during the day, and did not occur with every stimulation. The patient had noted it to be annoying and uncomfortable. The physician was not sure if it was muscle spasms. Additional information was received that the patient had an allergic reaction to a medication in december and was intubated for four days. Since that time she has had painful stimulation that is palpable through the skin of her neck. She also reports shortness of breath. She indicated that the settings were re-adjusted 8 weeks ago, but she is continuing to experience uncomfortable stimulations, stimulations that are palpable through the skin, shortness of breath, and palpitations. Clinic notes were received that the is referred for lead replacement. Notes state patient is still having 30 or more painful stimulations a day and they have discussed replacing leads. Notes state that they need to check the lead as it hasn¿t been the same since she was intubated. Regarding shortness of breath notes state doing well currently. Regarding dysphagia notes indicated stable related to vns and post intubation, discussed with her local ent and will refer for lead replacement. Complains of hoarseness due to vns. Cardiology notes state the patient denies chest pain, shortness of breath and palpitations. Notes again mention the palpable muscle spasm over the left anterior neck during stimulation. Surgery referral for the lead revision is to diagnose and or rule out vns as the cause. While surgery is likely it has not occurred to date.

 
Event Description

The lead was been received for analysis. Analysis is underway but has not been completed to date.

 
Event Description

The patient underwent lead replacement surgery. The patient's normal mode output current was disabled and magnet mode output current was left programmed on. Attempts have been made for product return however no product has been received to date. No additional relevant information has been received to date.

 
Event Description

Product analysis for the lead was completed and approved. An analysis was performed on the returned lead portions. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints.

 
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Brand NameLEAD MODEL 303
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 Key8552815
Report Number1644487-2019-00788
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/25/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/25/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/05/2019
Device MODEL Number303-30
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/13/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/24/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/28/2016
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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