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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 11/16/2011
Event Type  Malfunction  
Event Description

It was reported by a surgeon that high lead impedance was found after replacement of a patient's generator. The surgeon found that the lead was twisted near the generator site, and also that the patient had a damaged vagus nerve and a neuroma proximal of the lead next to the fixation area. The surgeon indicated that the patient was known to be a twiddler and it is suspected that the patient twisted the generator (as seen during surgery). The patient was described to be spastic and severely mentally disabled in accordance to the surgeon. X-rays were taken of the patient prior to surgery and no anomalies were noted on the review according to the treating neurologist.

 
Manufacturer Narrative

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

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2364121
Report Number1644487-2011-03025
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/16/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/08/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2011
Device MODEL Number302-20
Device LOT Number1985
Was Device Available For Evaluation? No
Event Location Other
Date Manufacturer Received11/16/2011
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/01/2008
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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