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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 07/18/2018
Event Type  Injury  
Event Description

Clinic notes were received for a patient's battery replacement referral due to "low" battery. It was stated in the notes that after vns settings were decreased for tolerability issues and the patient was weaned off medication (felbamate), the patient's seizures worsened substantially and the patient was vomiting without warning. It was also stated that the seizure clusters were lasting "twice as long as they used to be". Diagnostics indicated that the device was functioning within normal limits. No additional relevant information was 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 Key8141236
Report Number1644487-2018-02233
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 04/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/28/2016
Device MODEL Number103
Device LOT Number202828
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/04/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/26/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/17/2014
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: 12/07/2018 Patient Sequence Number: 1
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