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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 Fracture
Event Date 10/14/2013
Event Type  Malfunction  
Event Description

It was reported that a patient had been experiencing pain around her generator site since her last generator replacement. The pain was noted to have increased in frequency and severity over the course of the 5 years, and it was stated that she recently began having severe sharp pain at the site that worsens when trying to lift heavier items. The physician had instructed her to not pick things up. The patient now feels pain all the time and also experiences tingling in her hands and feet and pain in her ears. She was unsure if the newer events are related to vns. The patient stated not having any sort of trauma to the site. The pain is constant and seemed to be related to the placement of the device. The physician was recommending the newer device with the tachycardia detection as he believed it would benefit her seizure control. The patient further reported that she was experiencing sharp pains with vns stimulation. It was stated that she had issues with pain in the past and had settings adjusted at her last appointment, however the pain had now returned. At the patient's follow up appointment, it was noted that the patient's device was showing high impedance as observed from two different programming systems. The patient did not report any trauma that may have led to damage of the lead. It was further stated that after the device was disabled for the high impedance, the patient's painful stimulation resolved. Clinic notes were received also indicating that the patient was having more seizures with vns. Battery status was noted to be ok. No surgery has occurred to date. No additional relevant information was 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 Key8223185
Report Number1644487-2019-00018
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 04/23/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/07/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2008
Device MODEL Number302-20
Device LOT Number1188
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/01/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/22/2005
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: 01/07/2019 Patient Sequence Number: 1
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