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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 07/01/2018
Event Type  Injury  
Event Description

Clinical notes were received which reported that the patient is able to feel vns stimulation (i. E. ¿kick in from time to time), but the patient may still have small seizures and he may faint or pass out. The notes state the vns was interrogated during the vns visit and was found to show end-of-life of the battery. Information was received from the physician¿s nurse that the physician had no had no way to tell what the cause of the fainting was but that the patient appeared to have been doing better after his replacement although the reason for replacement was not due to the fainting. Regarding the relationship of the fainting to vns, the nurse did not directly answer that vns was to blame but appears herself to suspect that end of life was the cause of the patient's fainting. Although at the time when the fainting first began the device was not at end of service. No additional or 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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8519789
Report Number1644487-2019-00735
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/16/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/20/2015
Device MODEL Number104
Device LOT Number202801
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/19/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/17/2014
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: 04/16/2019 Patient Sequence Number: 1
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