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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  
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.

 
Event Description

Product analysis was completed for the returned generator. Visual examination of the generator showed markings typical of surgical procedures. The black dots noted on the generator (as reported in mfg report 1644487-2019-00771) were identified as burn marks, which indicated that the generator may have been exposed to an electrocautery tool. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. No other surface abnormalities were noted. Both interrogation and system diagnostic tests were performed resulting in status checks within normal limits. The battery measured to be at intensified follow-up indicator = no condition. The device output signal was monitored for more than 24 hours, while the generator was placed in a simulated body temperature environment. The generator showed no signs of variation in the output signal and demonstrated the expected level of output current. The generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator. No additional, relevant information was received to date.

 
Event Description

The explanted device was returned for analysis. Analysis has not been completed to date. Decoded programming data was received and reviewed. Impedances were noted to be within normal limits. No anomalies were observed through data review. 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,Followup,Followup
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 EXPIRATION Date07/12/2019
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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