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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 06/01/2013
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2013, noted that the patient experienced worsening of seizures and hospitalization over the summer. It was noted that his course was complicated by hyperammonemia on depakote and very poor nutrition. It was noted that the depakote was discontinued and clobazam was started. He was given a g tube and is getting isosource 1. 5 and has not been allowed to eat or drink by mouth. The patient's mother indicated that the patient is now having daily seizures that are mild - just repetitive movement of his eyes with unresponsiveness that lasts less than 30 seconds. It is unknown if the worsening of seizures is above pre-vns baseline frequency. An attempt to obtain additional information has been unsuccessful to date.

 
Event Description

Attempts to obtain additional information have been unsuccessful to date.

 
Manufacturer Narrative

 
Manufacturer Narrative

Date received by manufacturer; corrected data: the information reported on supplemental mfr. Report #01 was incorrect and should have been reported at 12/30/2013 rather than 12/30/2014.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
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 Key3513178
Report Number1644487-2013-03723
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/12/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/10/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2011
Device MODEL Number103
Device LOT Number2401
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/03/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/08/2009
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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