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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 High impedance
Event Date 09/24/2018
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that the patient was hospitalized due to increased seizures, and increased seizure duration and intensity. A company representative then checked the patient's generator and found high impedance and that the current was not being delivered. A new lead and generator were implanted on the right side of the patient. The generator was explanted, but the old lead was left in the patient in its entirety. Per the surgeon, no fluid or visible defects were seen on the lead. The physician believes the high impedance to have been due to scar tissue on the left vagal nerve. Attempts have been made for lead product information, but no relevant information has been received to date. No additional 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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7975863
Report Number1644487-2018-01839
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/17/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/18/2009
Device MODEL Number302-20
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/04/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 10/17/2018 Patient Sequence Number: 1
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