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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

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LIVANOVA USA, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury  
Event Description

It was reported that a patient was experiencing pain in her chest and neck stiffness. The patient attributed her pain to vns. According to the patient, her pain had been occurring for a long time. The patient's generator was explanted due to the chest tightness. The explanting surgeon also reported that the lead had been placed on the phrenic nerve instead of the vagus nerve. The explanted generator was discarded and is unavailable for analysis. Follow-up with the explanting physician indicated that the patient's normal mode output current had been programmed off sometime prior to the surgery, indicating that the pain was not stimulation related. The patient had been seen by a cardiologist because she had experienced the chest pain, and the cardiologist said that the patient's heart was ok. The patient had experienced inflammation around the electrode site and laryngeal nerve irritation, but it did not appear that the lead had been explanted. No additional relevant information has been received to date.

 
Event Description

Additional follow-up with the nurse at the explanting facility indicated that the surgeon was unable to locate the patient's vns electrodes during surgery, even after dissecting 8 centimeters into the nerve. This led the physician to believe that the patient's lead had been implanted somewhere behind the sternocleidomastoid muscle, causing the tugging sensation and pain in the neck and chest. The lead was confirmed to have also been explanted. The surgeon's office could not determine whether the pain was chronic or related to the vns. Follow-up with the patient's following neurologist indicated that the patient had previously complained that she did not like the vns, stating that it caused her a lot pain. No additional relevant information has been received to date.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
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 Key6768932
Report Number1644487-2017-04255
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 01/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/04/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2018
Device MODEL Number304-20
Device LOT Number202830
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/29/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/11/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/17/2014
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: 08/04/2017 Patient Sequence Number: 1
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