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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/04/2018
Event Type  Injury  
Event Description

It was reported that a patient was experiencing an increase in seizures. It was stated that the system diagnostics performed with the patient's head turned in different directions were within normal limits. X-rays were reviewed and noted no obvious fractures or sharp angles. Based on the images provided, there was no obvious cause for the increased seizures and no apparent malfunction. No further relevant information has been received to date.

 
Manufacturer Narrative

Corrected data: initial report inadvertently reported the event as a product problem instead of an adverse event. Outcomes attributed to adverse event, corrected data: initial report inadvertently did not report the outcomes of the adverse event. Describe event or problem, corrected data: initial report inadvertently did not include the device disablement. Type of reportable event, corrected date: initial report inadvertently reported the event as a malfunction instead of a serious injury.

 
Event Description

It was reported that the patient's autostimulation was programmed off when the increased seizures occurred, and the device was later turned off completely. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7551331
Report Number1644487-2018-00890
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 06/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/16/2019
Device MODEL Number106
Device LOT Number204177
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/21/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/24/2017
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: 05/29/2018 Patient Sequence Number: 1
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