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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/06/2014
Event Type  Malfunction  
Event Description

It was reported that the patient experienced increased depression and suicidal ideations, which were originally believed to be related to the vns battery being depleted. The patient was hospitalized for four days for suicidal ideations. The patient reported that her symptoms improved when her vns was functional, but her depression worsened after the battery depleted. The physician believed that the loss of vns therapy could have contributed to the suicidal ideations, but the patient's issues had several "layers" to them. However, it was later reported that the patient's device was still on and functional, which indicates that the increased depression and suicidal ideations were not related to low battery. Diagnostics were unable to be completed due to discomfort, and no changes were made to the settings. No further relevant information has occurred to date.

 
Event Description

Further information was received indicating that the patient's device was programmed off the next day at the patient's request, because she had thought the device was off for years prior. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
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 Key7509668
Report Number1644487-2018-00773
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/16/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/28/2008
Device MODEL Number102
Device LOT Number016740
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/22/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2007
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: 05/13/2018 Patient Sequence Number: 1
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