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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 01/18/2019
Event Type  Injury  
Event Description

It was reported that the patient has had an increase in seizures since the new device has been turned on. The patient presented seizures at the time of turn on and she does not tolerate the minimum parameters nor the system diagnostic. He decided to turn off and wait longer in case the nerve was affected at the time of manipulation during the lead placement. It was not possible to perform a post-operative system diagnostic because when they began the diagnostic the seizure came and the doctor orders to pull off the wand. Review of the device history record for the generator was completed. The device passed all specifications prior to distribution. The device history record was also reviewed for the implanted lead and the lead also passed all specifications. They have not tried to perform system diagnostics again since last time after surgery. The seizures increased only at the time of turn on the stimulator if vns is shut down the seizures are the same before the surgery. No additional or relevant information has been 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 Key8520377
Report Number1644487-2019-00718
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 07/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/16/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number005870
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/25/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/30/2018
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: 04/16/2019 Patient Sequence Number: 1
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