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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 06/04/2019
Event Type  Injury  
Event Description

It was reported that a patient has had an increase in seizures and is hospitalized. It was originally reported because the patient's sister needed information to be provided to the mri department for a brain mri. Further follow up for additional information from the physician has been made and no information regarding the physician's assessment of the increase in seizures has been received to date. Information was received that the patient uses recreational drugs. No additional 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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8740121
Report Number1644487-2019-01211
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Type of Report Initial
Report Date 08/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/15/2019
Device MODEL Number106
Device LOT Number5242
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/08/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/04/2017
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: 06/27/2019 Patient Sequence Number: 1
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