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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2018
Event Type  Malfunction  
Event Description

It was reported that the patient was experiencing increase in seizures and pain on the life side of their body and also felt pain starting in their fingers and working its way up their left arm, back, and their leg. The physician ran diagnostics on the patient's device, and the reported diagnostics were within normal limits. The physician evaluated the patient for pain and stated that she does not believe the pain was related to vns since the pain does not coincide with vns stimulation or the placement of the vns device. The physician also explained to the patient that they magnet may not be able to able stop all seizures immediately, however it could help shorten the seizure. It was also stated that the physician does not believe that the patient has reached proper dosing levels. The physician decided to disable the patient's device in order to evaluate the complaints of pain and seizures. No other relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 105
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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8103990
Report Number1644487-2018-02141
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 02/21/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/26/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number105
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/30/2019
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

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