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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 Premature End-of-Life Indicator
Event Date 12/20/2018
Event Type  Malfunction  
Event Description

It was reported that a patient would be having an urgent battery replacement due to low battery. The generator was suspected to have prematurely depleted as the physician's office was notified that the generator may have "shorter than expected battery longevity". The generator was found to have low battery at the patient's last interrogation and it was reported that the patient was also experiencing a sudden increase in seizures. A battery life calculation was performed to estimate remaining battery life with the programming data made available to the manufacturer's, and did not estimate that the device would have reached low battery at this time. Review of the device history records confirmed that the device was laser-routed and is susceptible to prematurely deplete. The device passed all quality inspections prior to distribution. Follow up with the physician's office noted that the increased seizures were first noted a "couple months" before per the patient. The last diagnostics provided were from mid-october and showed that the device was functioning at intended. 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 Key8246819
Report Number1644487-2019-00075
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/06/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/15/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/18/2017
Device MODEL Number106
Device LOT Number203806
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/08/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/12/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/31/2016
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: 01/15/2019 Patient Sequence Number: 1
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