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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/27/2019
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that a patient was experiencing constant stimulation, pain, and coughing "all the time". The patient was said to be going to the er. Clinic notes and a referral form were received reporting that the patient was referred for surgery due to constant stimulation causing pain, coughing, and shortness of breath. The device was disabled on (b)(6) 2019 for the adverse events. The patient underwent replacement surgery. It was noted pre-operatively that the device was already disabled upon interrogation at surgery. No pre-operative diagnostics were performed. During the surgery, the surgeon looked at the device being explanted and stated seeing some dot marks. At the patient's follow up appointment, it was clarified that the patient's pain, which was in the neck area, had resolved after the device was disabled. Prior to disablement, the patient felt like the pain was constantly going off. No device was returned to date. No additional, relevant information was received to date.

 
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Brand NamePULSE GEN MODEL 106
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 Key8510188
Report Number1644487-2019-00713
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 05/15/2019
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 MODEL Number106
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/11/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/06/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/14/2017
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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