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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 03/26/2019
Event Type  Injury  
Event Description

It was reported that the patient was referred for prophylactic battery replacement and that the patient had experienced a lot of seizures. The physician had just began seeing the patient and was not aware of their pre-vns seizure baseline or external factors that may have been contributing to the increase in seizures. It was reported that the patient's settings were lowered. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

 
Event Description

It was reported that the patient's generator was replaced due to battery depletion. The explant facility does not historically return explanted products; therefore, return of the suspect product is not expected to date. No further relevant information has been received to date.

 
Event Description

Generator was received into product analysis (pa). Generator analysis was completed and reviewed. The generator was interrogated during bench testing with pulsedisabled and end of service (eos) warning set. The pulsedisabled byte could not be reset. Therefore, system diagnostics, final electrical testing and monitoring could not be performed. The battery measured 2. 061 v with 119. 305% of the battery having been consumed. The electrical performance of the generator, as measured in the pa lab, will be used to conclude that no anomalies exist and the end-of-service (eos) condition is an expected event. There were no additional performance, or any other type of adverse conditions found with the generator. No additional relevant information has been received to date.

 
Event Description

Operative notes were received which provided the patient's generator implant information.

 
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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 Key8527029
Report Number1644487-2019-00740
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/08/2020
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 Date07/19/2014
Device MODEL Number103
Device LOT Number202174
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/18/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/18/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/10/2012
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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