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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN 103 GENERATOR

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LIVANOVA USA, INC. PULSE GEN 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2019
Event Type  Injury  
Event Description

It was reported through clinic notes that during the visit the patient complained of possible vns malfunction and stated that she felt that she has increasing seizures in the last few weeks. The physician noted that her battery needed to be changed as it was nearing end of life. The manufacturer's battery life calculation with available data did not support low battery. No known surgical intervention has occurred to date. No further relevant information has been received to date.

 
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Brand NamePULSE GEN 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 Key8745382
Report Number1644487-2019-01240
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
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 Received06/28/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/01/2015
Device MODEL Number103
Device LOT Number3805
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/09/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/03/2013
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: 06/28/2019 Patient Sequence Number: 1
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