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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

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CYBERONICS - HOUSTON LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Event Date 10/01/2017
Event Type  Injury  
Event Description
It was reported that the patient was experiencing swelling in the neck.The physician was unsure if it was related to vns and referred the patient for x-rays in order to further assess the swelling.The swelling was reported as constant and unrelated to stimulation.The lead impedance was reported as within normal limits.Follow up with the physician revealed that there was no trauma or patient manipulation to the area.The physician did not think the swelling was related to the vns, but due to the asymmetry of the swelling, which was only on the vns side of the neck, they were unable to rule it out.The swelling was not associated with stimulation.There was no interventions planned or taken at that time.It was later reported that the patient's neck swelling had gone down and the patient was asymptomatic with no pain or discomfort.X-ray images were received by the manufacturer and reviewed.The lead visibility varies throughout the length of the lead visible in the provided images as only the neck x-rays were provided.The review was unable to assess if strain relief was present and placed according to labeling due to the unorganized placement of the lead in the neck.The review was able to identify only one tie-down.No apparent sharp angles or gross fractures were identified in the visible portions of the lead.The patient's previous lead could be observed in the image.Based on the x-rays received, the cause for the swelling cannot be determined.It was later reported that the patient was complaining of something not being right.The patient the proceeded to pull a two inch piece of the remaining lead left over from the previous lead revision.The patient believed it was an ingrown hair and pulled it out with tweezers.It was stated that it came out without pain and that the patient has not had further issues.The medical professional believed that the previous edema was caused by the remaining portion of the previous lead.No additional relevant information has been received to date.
 
Event Description
Follow up with the company representative revealed that the extracted lead portion had been discarded.
 
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Brand Name
LEAD MODEL 302
Type of Device
LEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key7740319
MDR Text Key115723631
Report Number1644487-2018-01317
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date04/01/2010
Device Model Number302-20
Device Lot Number200471
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 07/16/2018
Initial Date FDA Received08/01/2018
Supplement Dates Manufacturer Received08/03/2018
Supplement Dates FDA Received08/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/02/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age54 YR
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