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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 Type  Injury  
Event Description

It was reported that a patient's was having their generator replaced as the patient was having pain at his generator site that happens sporadically, lasts for 5 seconds, and makes the patient "feel funny" for about 15 seconds afterwards. Clinic notes were received and stated that "vns device is zapping patient". It was noted that the patient would feel his heart fluctuate up and down after. It was noted that the last diagnostics indicated that the device was functioning as intended. No known replacement surgery has occurred to date. No further relevant information was 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 Key8123336
Report Number1644487-2018-02186
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/02/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/06/2015
Device MODEL Number105
Device LOT Number3813
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/18/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/09/2013
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: 12/02/2018 Patient Sequence Number: 1
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