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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 12/01/2018
Event Type  Injury  
Event Description

Handwritten clinical notes were received which were mostly illegible, but a statement was observed stating the vns battery was found to be weak and the patient is having more seizures. The patient was referred for replacement due to this. Additionally, a battery life estimation was performed with the available data which resulted in >10 years until expected neos and did not support a depleted battery status. No relevant surgical intervention is known to have occurred to date. No additional or 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 Key8510942
Report Number1644487-2019-00715
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/28/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/12/2016
Device MODEL Number105
Device LOT Number203228
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/07/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/15/2015
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: 04/12/2019 Patient Sequence Number: 1
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