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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL UNK GENERATOR Back to Search Results
Event Date 02/01/2011
Event Type  Injury  
Event Description

It was reported by the patient's father that the vns patient had initially experienced a decrease in simple seizures with vns therapy however her complex seizures had increased. The patient then tried deep brain stimulation so the vns was turned off. After some time on deep brain stimulation, the patient had some large seizure episodes which prompted the physician to stop deep brain stimulation and resume vns in (b)(6) 2011. The patient was also noted as having difficulty breathing during magnet stimulation and therefore is reluctant to perform magnet activations to abort seizures. The patient's deep brain stimulator has recently been reactivated as per the patient's father. The patient's settings have been turned down to help with the difficulty breathing. The patient's neurologist office has declined to provide any further information.

 
Event Description

Attempts for the patient's vns model and serial number information were unsuccessful as the site indicated that signed patient consent is required for release of medical records.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL UNK
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 grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2487671
Report Number1644487-2012-00677
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup
Report Date 02/10/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received04/12/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 03/11/2012 Patient Sequence Number: 1
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