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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 302-30
Event Date 01/16/2013
Event Type  Malfunction  
Event Description

On (b)(6) 2013 clinic notes were received dated (b)(6) 2013 that indicated the patient has been experiencing an increase in seizures; the patient had about 30 abdominal rushes (averaging about 6 per month) which is an increase since before (4 per month). The patient also complained of ¿pulling of her vns¿ about once a month, lasting for several minutes, especially when she is laying down at night. The patient¿s settings were noted to be output=3. 25ma/frequency=20hz/pulse width=250usec/on time=60sec/off time=1. 1min/magnet output=3. 50ma/magnet on time=60sec/magnet pulse width=250usec. Diagnostics showed results within normal limits of output=ok/lead impedance=ok/impedance value=1673ohms/neos=no. The clinic notes dated (b)(6) 2013 indicate that the patient has had 20 auras but no seizures since the office visit on (b)(6) 2013. Good faith attempts for further information from the physician were unsuccessful.

 
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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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3170182
Report Number1644487-2013-01785
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/22/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/14/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2013
Device MODEL Number302-30
Device LOT Number201027
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/22/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/18/2009
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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