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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2016
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient was experiencing painful stimulation at her jaw. The patient also had pain in her neck and jaw which made it difficult to move. Therefore the patient was being referred for a possible lead revision due to the pain. Because of these symptoms the patient was experiencing issues with depression. No additional relevant information has been received. No surgical interventions are known to have occurred to date.

 
Event Description

Further information was received that the surgeon intended to perform surgical intervention for the lead when the generator needed to be replaced since at this time, the generator was still functional. No further relevant information has been received to date.

 
Event Description

Incoming information was received indicating the patient's device was to be upgraded and the patient was referred for surgery. Follow up with the patient stated that generator replacement was needed due to low battery. It was stated that the surgeon would also take a look at her lead as she reported that the lead was "all clumped up under her neck" and that when she turns her head to the right, she can see the wiring under the skin. She stated she could see the "clump" without turning her head. The patient also reported that her generator had migrated and the surgeon stated that when the generator was replaced, he would ensure the device was better secured in the pocket. It was further stated that the patient has near constant ear and toothache believed to be with stimulation and attributed to vns as she had seen both a dentist and ent. She reported a scratchy voice that worsens with stimulation and makes her feel like she has to gasp for air to continue conversations. It was noted that the patient otherwise has been doing well with vns and sees decrease in seizures with the device. The replacement surgery occurred. It was stated that the leads were not revised as they tested to be functioning within normal limits. Post-operation diagnostics showed the devices were functioning as intended. No device was expected for return per the hospital policies. No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 103
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 Key6914216
Report Number1644487-2017-04543
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 09/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/04/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2015
Device MODEL Number103
Device LOT Number3832
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/17/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/06/2014
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: 10/04/2017 Patient Sequence Number: 1
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