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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 01/20/2010
Event Type  Malfunction  
Event Description

It was reported that high lead impedance was read in system diagnostics during a follow up visit with the treating neurologist. The patient had reported an assault and trauma to the neck area in (b) (6) 2009. System diagnostics were fine (ok/ok/1/no) in (b) (6) 2009 after the incident and the high lead impedance (7/limit/high/no) was encountered on (b) (6) 2010 after performing both a system and normal mode diagnostic test. The device was programmed off by the neurologist and the patient was recommended for x-rays. X-ray review from the manufacturer revealed the generator was placed in the left chest in normal orientation. The filter feed-thrus appeared to be intact. The lead wires appeared to be intact at the connector pin and the lead connector pin appeared to be fully inserted into the generator connector block. Furthermore, no acute angles or discontinuities were observed in the visualized portion of the device, though a small portion of the lead behind the generator could not be visualized or assessed. The patient's positive electrode appeared to be misaligned with the negative electrode, which may be due to electrode/nerve detachment. A clinic note was received from the office of the treating neurologist at the time of the incident which indicated the patient was grabbed by the throat and after he was released, he felt the lead was moved and was hoarse due to the trauma. Follow up with the treating neurologist revealed the patient was doing well with no adverse events and revision surgery had been scheduled and was likely to occur.

 
Manufacturer Narrative

Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
suite 600
houston , TX 77058
2812287200
MDR Report Key1613594
Report Number1644487-2010-00335
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/21/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/17/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2008
Device MODEL Number302-20
Device LOT Number1181
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/21/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2005
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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