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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; Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction  
Event Description

A patient reported that she was experiencing worsening depression and suicidal ideations. The patient's vns system was implanted in 2007 and had reportedly been helpful in managing her depression in the past. It was believed that the generator battery was dead, resulting in the worsening symptoms; however, the manufacturer's battery life calculation did not support a depleted battery, and recent device settings and diagnostics have not been received by the manufacturer to date. The patient was referred for generator replacement surgery, but surgery has not occurred 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 Key7573873
Report Number1644487-2018-00967
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 07/13/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2009
Device MODEL Number302-20
Device LOT Number200395
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/18/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/19/2006
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: 06/06/2018 Patient Sequence Number: 1
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