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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 02/14/2014
Event Type  Injury  
Event Description

On (b)(4) 2013, it was reported that the vns patient was turned on two weeks after implant and then increased every four weeks by 0. 25 ma up to the patient's current settings on (b)(6) 2013. All other parameters remained constant. The patient's settings were noted to be output=1. 5ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=5min/magnet output=1. 75ma. Diagnostics were last performed on (b)(6) 2013 and were all "ok" with a 1880 ohms lead impedance. There has been no known trauma since implant. It was reported that the patient is having redness and slight swelling at the site of the neck incision which is concerning the patient's parent but not giving the patient any particular discomfort. This was first noticed on (b)(6) 2013. The area was weeping slightly and the patient saw their general practitioner the week prior who prescribed a course of antibiotics which has just been completed. The nurse stated that they can palpate a hard area under the wound which could be a protrusion of a tie-down. The patient is not feeling discomfort and the "hard area" is thought to be the problem. It was later reported that the physician believes the event is due to the presence of the lead, possibly the tie-down. No cultures were taken or planned. Antibiotics were given as a precaution. There have been no changes to diet or medication that are thought to have contributed to this problem.

 
Manufacturer Narrative

 
Event Description

On (b)(6) 2012 additional information was received when it was reported that the wound was opened up by one of the registrars. The tie-down clip had moved and they also cleaned out the wound with antibiotics. When the nurse saw him, it had healed up well. The patient has seen the physician again since then and the scar was oozing a little again. A swab has been taken and dressings were put on it for the moment.

 
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Brand NameLEAD MODEL 304
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3072402
Report Number1644487-2013-01121
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/27/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/23/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number304-20
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/30/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 04/23/2013 Patient Sequence Number: 1
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