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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/30/2018
Event Type  Malfunction  
Event Description

It was reported that a patient was experiencing an increase in depression and was concerned her device was not working properly. The patient saw her psychiatrist and diagnostics were performed on her device. The diagnostics indicated that the device was functioning as intended with no noted anomalies or malfunctions. It was stated that her physician also believed the device was not stimulation as much as before. The patient stated that she was feeling okay again after the appointment. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 104
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 Key7543759
Report Number1644487-2018-00869
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial
Report Date 06/20/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/25/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2015
Device MODEL Number104
Device LOT Number3786
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/20/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/07/2013
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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