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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

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CYBERONICS, INC. LEAD MODEL 303 Back to Search Results
Model Number 303-20
Event Date 08/01/2014
Event Type  Injury  
Event Description

Clinic notes were received dated (b)(6) 2015. Notes mention that the patient was seen for follow-up regarding her neck pain associated with vns. The patient states that swiping the magnet causes uncontrollable pain. Today he reduced her magnet settings to match the normal mode of 1. 75ma, 30sec, 250 pulse width. Normal mode diagnostics were ok. The patient noted severe pain in the areas where her vns wire seemed to protrude from her neck. The physician repeated the x-ray of her neck and compared to her prior x-ray and showed no change. The patient feels the vns has shifted. The patient had a referral in place to have the surgeon evaluate vns due to the migration focal pain and to evaluate to see if there needs to be repositioning of the device. The physician stated that way the wire is looped is very uncomfortable and has been ongoing since insertion but recently the issue is worse. The lead was replaced on (b)(6) 2015. The explanted device has not been received to date.

 
Event Description

The lead was returned for analysis on 04/24/2015. Operative notes state that the electrode appeared to be in good shape throughout its course. It seemed to have good adhesion and attachment to the vagus nerve. There were no obvious flaws or problems that were identified. Analysis of the device is underway but has not been completed to date.

 
Event Description

Product analysis for the explanted lead was completed and approved on 05/20/2015. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions.

 
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Brand NameLEAD MODEL 303
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4707673
Report Number1644487-2015-04503
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 03/26/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/20/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2017
Device MODEL Number303-20
Device LOT Number202401
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/20/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/13/2013
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: 04/20/2015 Patient Sequence Number: 1
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