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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 05/23/2013
Event Type  Malfunction  
Event Description

It was reported that this vns patient underwent surgical debridement (without disconnecting the generator) due to chronic inflammation in the surgical wounds in the neck and chest. The patient was seen for a vns check, and system diagnostics indicated high impedance (10000 ohms). The device was disabled. During the operation, unipolar electric fields were used. It was believed that the patient had a damaged generator, lead, or both. The patient was referred for surgery. Follow-up showed that the chronic inflammation was believed to neck granulation that was first seen a few weeks prior to surgical intervention. The physician stated that diagnostics prior to the surgery were within normal limits; however, afterwards, they indicated high impedance. No x-rays were taken. Cultures were taken at the wound sites; however, the results have not been provided. Surgery is likely but has not taken place. No additional information has been returned.

 
Event Description

It was reported that the patient underwent revision surgery on (b)(6) 2013. It was reported that the device "worked 100%". It was later reported that the patient was seen for checkup and that it was found that the patient has a "broken lead". It was reported that during the office visit diagnostics were performed with the patient's head a different orientations. It was reported that when the patient turned his head to one direction high impedance was always observed. Then the patient turned his head the opposite direction the impedance was "ok". The patient was referred for surgery and the device was programmed off. Surgery is likely, but has not occurred to date.

 
Manufacturer Narrative

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization and confirmed all quality tests were passed for both the generator and lead prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

Additional information was received indicating that cultures returned positive for (b)(6).

 
Manufacturer Narrative

Previously submitted mdr inadvertently omitted the outcome of culture results. This report is being submitted to correct this information.

 
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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 Key3173892
Report Number1644487-2013-01810
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/23/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/17/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2015
Device MODEL Number304-20
Device LOT Number3182
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/14/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/23/2011
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: 06/17/2013 Patient Sequence Number: 1
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