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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/15/2017
Event Type  Injury  
Event Description

It was reported to a company representative by a surgeon¿s office that a vns patient wants to have her vns removed. Follow-up to the treating neurologist¿s office provided the patient was last seen on (b)(6) 2016 and requested that device be turned off due to perceived weight loss. The neurologist turned off the device at that time and told the patient to contact the surgeon if she wanted it removed. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

 
Event Description

Clinic notes were received for surgical referral providing the patient reports it won¿t allow her to gain weight.

 
Event Description

The patient was referred for replacement due to decreased appetite and weight loss. The neurologist did not know if the decreased appetite and weight loss was related to stimulation or presence of the device. Programming history was reviewed and no programming anomalies were seen. Surgery is likely but has not occurred to date. No additional or relevant information has been received.

 
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Brand NamePULSE GEN MODEL 106
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 Key6405006
Report Number1644487-2017-03384
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/09/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/14/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2018
Device MODEL Number106
Device LOT Number3382
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/20/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/14/2016
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: 03/14/2017 Patient Sequence Number: 1
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