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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 09/01/2017
Event Type  Injury  
Manufacturer Narrative

 
Event Description

The patient reported that they were having difficulty swallowing, catching their breath, and felt some tightness in their throat. It was reported to first occur with magnet stimulation, and has been getting worse in the past six months. The patient stated that recently the difficulty swallowing, catching her breath and tightness in her throat is constant, and not only occurring with stimulation. The patient stated that they were hospitalized and an upper gi test was performed that came back negative. The patient has not seen a neurologist in some time and was questioning if her battery needed replacement. The patient does not have a current neurologist she visits. No other relevant information has been received to date.

 
Event Description

Additional information was received from the patient's previous neurologist who stated that the patient has not been seen since (b)(6) 2018, and the doctor no longer sees the patient. The device was not interrogated at this time, and there were not medication changes. The patient never mentioned any difficulty swallowing, shortness of breath or throat tightness to the neurologist. No other relevant information has been received to date.

 
Event Description

Additional information was received via clinic notes that this patient¿s primary care provider is concerned that the patient¿s throat cancer is returning as the patient has experienced throat pain and hoarseness. Patient reports symptoms have been worsening recently. Patient reports at first inability to tolerate solids and no difficulty tolerating liquids. Patient reports history of throat cancer 2007 when they were treated with surgery as well as chemotherapy. The notes also report that the patient was a former smoker. No other relevant information has been 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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7403911
Report Number1644487-2018-00533
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial
Report Date 08/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/13/2014
Device MODEL Number103
Device LOT Number3540
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/31/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 04/06/2018 Patient Sequence Number: 1
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