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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 Problems Fracture; Mechanical Problem; Device Contamination with Body Fluid
Event Date 10/09/2018
Event Type  Malfunction  
Event Description

It was reported that the epileptologist ordered x-rays for this patient because there was an issue with the leads. X-ray assessments were received and stated that the device has an unchanged appearance, and the reason for the exam was that the device was not working. Device leads were noted and were stated to be unchanged compared with appearance on chest x-ray from (b)(6) 2018. Clinic notes dated (b)(6) 2018 state that the patient is not feeling the device, but it burns in the left posterior neck when the patient swipes the magnet and no reported side effects. Diagnostics from this visit were indicated to be abnormal because the lead impedance is high. The doctor decreased the pulse width, and it was stated that this was much better tolerated. The physician stated that the cause of the burning paint the patient is experiencing is unknown. Clinic notes were also received from (b)(6) 2018 stating that the vns was interrogated and is functioning normally and diagnostics were stated to be ok at this time. Later in the clinic notes the physician states that they ¿will investigate lead disfunction in vns¿ and ordered x-rays at that time. X-rays were provided and reviewed by the manufacturer. Chest x-rays were not provided and therefore the generator was unable to be assessed. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. No sharp angles or gross discontinuities were identified in the visible portion of the lead. The cause of the patient¿s painful stimulation could not be determined based on the images provided. Note that incomplete pin insertion and the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images. No known surgical intervention has occurred to date. No other 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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8088687
Report Number1644487-2018-02106
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/16/2016
Device MODEL Number304-20
Device LOT Number202275
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/22/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/14/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/17/2012
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: 11/20/2018 Patient Sequence Number: 1
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