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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 03/01/2013
Event Type  Malfunction  
Event Description

It was initially reported that the patient had high impedance (7814 ohms). The patient was also experiencing an increase in seizures and burning in the neck. The burning in neck was from (b)(6) 2013 at which time the generator was disabled and the burning resolved. The burning was reported to be worse when the patient turned her head to the right. Additional information was received from the physician. It is unclear when the increase in seizures started but it started with many generalized seizures which the patient not had gtc for many years. The physician indicated that the increase in seizures and neck pain were related to vns but did not provide the specific relationship but may be related to the high impedance. The increase in seizures was above pre-vns baseline and all seizure types that the patient has increased. There were no causal or contributory programming changes, medication changes or other external factor that preceded the onset of the increase in seizures or pain. There was no manipulation or trauma the contributed to the high impedance. For the increase in seizures the patient had onfi dosage increased and lead and generator replaced. For the pain the vns was turned off prior to replacement. The pain in the neck was not always occurring with stimulation. The patient had x-rays taken however they have not been provided to the manufacturer for review. The office does not know if the x-rays will be sent in as there was no indication in the notes that they will be sent to us and this office no longer had the x-rays. The patient had a generator and lead replacement. Good faith attempts for product return have been unsuccessful to date. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.

 
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Brand NameLEAD MODEL 302
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 Key3089414
Report Number1644487-2013-01219
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/02/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/02/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/29/2008
Device MODEL Number302-20
Device LOT Number945
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/20/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/18/2005
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: 05/02/2013 Patient Sequence Number: 1
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