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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 03/29/2018
Event Type  Injury  
Event Description

It was reported that the patient was having an increase in seizures. The patient¿s device was at intensified follow up indicator at their latest appointment. The patient¿s seizures have been worse over the past year with 1-2 tonic-clonic seizures/month. The physician did not know the cause of the seizures, or if the seizures were above their pre-vns baseline frequency. Programming history was reviewed for the patient. No anomalies were seen. A battery life calculation was performed, and the device was expected to have 1. 3 years to near end of service. Surgery is likely but has not occurred to date. No additional or 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 Key8528559
Report Number1644487-2019-00745
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 05/14/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/18/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/04/2015
Device MODEL Number103
Device LOT Number202458
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/07/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/26/2013
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: 04/18/2019 Patient Sequence Number: 1
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