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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 11/24/2014
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that a patient wanted their device explanted as it did not help her seizure control and it was negatively affecting her sleep. Operation notes were received confirming the explant. The generator was removed, and the leads were detached form the nerve and completely removed. 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 Key8538504
Report Number1644487-2019-00758
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/24/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/23/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/13/2016
Device MODEL Number103
Device LOT Number3884
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/30/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/30/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/13/2014
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: 04/23/2019 Patient Sequence Number: 1
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