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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2017
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported via clinic notes received that the patient was referred for vns explantation surgery due to chest and jaw pain and the desire for mris. It was stated that the patient was seizure free for a year even with the vns disabled. Follow up revealed that the reason the vns was disabled was due to chest cramps experienced by the patient. The surgery to explant the vns was reported as both for the patient's comfort and to preclude serious injury as the patient had experienced pain and no longer used the vns. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 105
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 Key8163186
Report Number1644487-2018-02291
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 03/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/05/2015
Device MODEL Number105
Device LOT Number3729
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/08/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/05/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/05/2013
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: 12/13/2018 Patient Sequence Number: 1
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