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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

The physician reported that the patient experienced increased seizures, body twitching, numbness in the right arm, and occasional left leg weakness. The physician attributed these events to the vns generator being at a low battery status. The physician clarified that the patient's current increased seizure levels are at/below pre-vns levels. The patient has been referred for vns replacement surgery due to these events. No known surgical intervention has occurred to date. No other relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 103
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 Key8380159
Report Number1644487-2019-00356
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 05/03/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/28/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/20/2011
Device MODEL Number103
Device LOT Number201274
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/22/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/09/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2009
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: 02/28/2019 Patient Sequence Number: 1
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