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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 1000 GENERATOR Back to Search Results
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/25/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

The patient's fiancé reported that the vns was turned up too high at the generator replacement surgery. It was noted that the patient's quality of life is not good, and at the "higher" output current the patient was feeling dizzy, nauseous, and "felt like having seizures", and she "felt like she is being overmedicated". Further follow up confirmed that the patient's generator output current was reduced as a result of the patient's symptoms, and that the patient's symptoms resolved after the parameter adjustment. The physician noted that the patient was feeling "poorly" due to pain and feeling like they were getting too strong of a stimulation. The physician reported that the patient experienced increased seizures due to being very stressed and very much in pain/discomfort, which stemmed from the vns output current being set too high. No other relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 1000
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 Key8556724
Report Number1644487-2019-00803
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 05/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number1000
Device LOT Number204252
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/26/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/27/2017
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: 04/26/2019 Patient Sequence Number: 1
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