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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR Back to Search Results
Model Number 101
Event Date 10/01/2012
Event Type  Injury  
Event Description

On (b)(6) 2013 it was reported that the vns patient wants to have the vns explanted because her generator protrudes and it bothers her. The patient was seen on (b)(6) 2013 and they were unable to interrogate the patient's vns likely due to end of service. The last time the patient was seen was about a year ago and they were able to interrogate her vns without any problems. The patient had a new seizure type in (b)(6) 2012 which the patient reports that she has never had before. It was later reported that the patient now wants the vns replaced instead of explanted. Good faith attempts for further information from the physician have been unsuccessful. A battery life calculation was performed which showed 1. 73 years remaining until eri=yes. Although surgery is likely, it has not occurred to date.

 
Event Description

Additional information was received on (b)(4) 2013 when the physician provided clinic notes from the (b)(6) 2013 visit. It was noted that currently the patient's seizures are fairly well controlled; she had a big seizure approximately 3 months ago. The patient is currently having small spells a few times a month, but the patient stated that this is the best seizure control she has had so far. Her vns has not been interrogated for the last several years (5+ years) and the patient's vns was interrogated that day and the settings were increased to achieve better seizure control. No further information was provided from the physician.

 
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Brand NamePULSE GEN MODEL 101
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2947674
Report Number1644487-2013-00312
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/07/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2003
Device MODEL Number101
Device LOT Number5423
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/07/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/05/2002
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: 02/07/2013 Patient Sequence Number: 1
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