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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 10/03/2013
Event Type  Malfunction  
Event Description

Additional information was received stating that the vns patient¿s device was tested during an office visit on (b)(6) 2013 and normal mode diagnostic results showed high impedance (dc dc ¿ 7). The patient¿s device was not disabled following the high impedance observation. The patient¿s physician stated that the patient¿s lead likely cracked from the patient¿s seizures. A mass was noted on the patient¿s neck during an office visit on (b)(6) 2013. The patient¿s radiology exam stated that the sonographic findings were most consistent with a hematoma at the patient¿s left neck. An abscess was not expected based on the absence of fever, wbc count, and the overlying redness and swelling.

 
Manufacturer Narrative

Date of event; corrected data: additional information indicates that high impedance was observed on (b)(6) 2013.

 
Manufacturer Narrative

 
Event Description

On (b)(6) 2013 it was reported that the patient has high lead impedance. The patient had a fall with seizures approximately 3 weeks ago striking her neck area and developed a hematoma in the neck. When her vns was checked, she was found to have high impedance. It was stated that the surgeon was treating the hematoma with cold and warm compresses but the hematoma did not go down. No x-rays were taken due to patient¿s ¿mr¿ (possibly mental retardation). Patient went to surgery on (b)(6) 2013 to have a full revision but when the surgeon opened the left neck he saw a huge hematoma that entwined the nerve including the part where the helices were. The surgeon said he would not implant another lead/generator on the left side because of the extensive hematoma. The surgeon then elected to place the lead and the generator on the right side due to the severe hematoma and resulting scar tissue on the left side. The explanted lead and generator have not been returned to the manufacturer for product analysis to date.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3494999
Report Number1644487-2013-03657
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/06/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/02/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2015
Device MODEL Number304-20
Device LOT Number201680
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/11/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/07/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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