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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 101 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 101 GENERATOR Back to Search Results
Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2003
Event Type  Injury  
Manufacturer Narrative

 
Event Description

Clinic notes were received for vns removal. The notes indicated that vns will be removed as it has been off for over 5 years. The patient has been undergoing chemotherapy for throat cancer. The patient reported that the vns is bothersome as he feels it in his throat as if it is on. The device according to the patient was turned off 4 years ago for lack of efficacy. The device was interrogated during this appointment and confirmed to be off. Battery was stated to show ifi-yes (although model 101 so likely neos). Notes indicate that the patient reports erratic sensation of vns stimulation in the throat. He has seen gastroenterology who performed endoscopy and reported abnormalities in the throat. The patient does not believe the report and suspects it¿s the vns and is adamant that he wants referral for removal. The abnormalities in the throat are still be looked into. No surgical intervention has occurred to date and no additional or relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 101
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 Key8508514
Report Number1644487-2019-00706
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2003
Device MODEL Number101
Device LOT Number7151
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/12/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/07/2002
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: 04/12/2019 Patient Sequence Number: 1
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