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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 01/01/2018
Event Type  Injury  
Event Description

It was reported that the patient was experiencing painful stimulation and pressure in the chest, shortness of breath, and left arm pain. The diagnostics were found to be within normal limits. It stated that the patient was experiencing cardiac pain symptoms, but the physician did not think they were related to the vns. The vns parameters were programmed at various settings in an attempt to replicate the pain described by the patient. The patient was referred for a complete cardiac checkup with a holter monitor in order to rule out any relationship between his chest pain and vns. The patient requested removal as he had found the generator uncomfortable and the area was sore due to being bumped regularly when playing with his children. The patient underwent vns explantation surgery. The explanted products have not been received by the manufacturer to date. No additional relevant information has been received to date.

 
Event Description

Follow up with the surgeon's office revealed that the surgical intervention was for the patient's comfort.

 
Event Description

The explanted generator and lead were received by the manufacturer. Analysis on the lead was approved. Note that since the lead¿s electrodes were not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions. Analysis on the generator has not been approved to date.

 
Event Description

Generator product analysis was completed. The reported pain, painful stimulation, and dyspnea could not be evaluated in the product analysis, or pa, lab. However, proper functionality of the generator was verified in the pa lab. The septum was not cored, eliminating the possibility of a potential unintended electrical current path through body fluids, which addresses the allegations of pain and painful stimulation. The generator was placed in a simulated body temperature environment and the output signal was monitored for more than 24 hours. No signs of variation in the signal were observed and diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. There were no performance of other adverse conditions found with the generator.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7544133
Report Number1644487-2018-00871
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 07/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number5381
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/13/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/09/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/04/2017
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: 05/25/2018 Patient Sequence Number: 1
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