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U.S. Department of Health and Human Services

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

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

An abstract article was received for review. The title was. "outcomes of vagus nerve stimulation (vns) in pediatric epilepsy"authors: c. D. Yu, i. Abdelmoumen, s. Ramgopal, c. Powell, k. Remy, m. Libenson, j. Madsen, a. Rotenberg, t. Loddenkemperinstit: mcgill university, boston children's hospital. The abstract reported charts about all patients implanted with the vns at a single center between (b)(6) 1997 and (b)(6) 2011. 252 patients were identified. Complete follow-up data was available for 69 patients. Of the excluded patients, 6 had treatment discontinued during the 12 month follow-up period. Reasons for discontinuation included infection (n=3), nausea (n=1), skin breakdown (n=1), and perceived lack of efficacy (n=1). Sixteen of the 69 patients experienced adverse effects which did not warrant discontinuation of therapy, including voice changes, coughing, throat tickle, difficulty sleeping, and pain over the vns area. This report is to capture one patient who discontinued treatment for skin breakdown. At this time no further information is available.

 
Manufacturer Narrative

(abst 1. 285. ),2012 :abstract "outcomes of vagus nerve stimulation (vns) in pediatric epilepsy" authors: c. D. Yu, i. Abdelmoumen, s. Ramgopal, c. Powell, k. Remy, m. Libenson, j. Madsen, a. Rotenberg, t. Loddenkemper instit: mcgill university, boston children's hospital.

 
Event Description

On (b)(6) 2013 the full article was received.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL UNIK
Type of DevicePULSE GEN MODEL UNIK
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 Key2784335
Report Number1644487-2012-02597
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/17/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/11/2012
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? Yes
Distributor Facility Aware Date09/17/2012
Event Location Other
Date Manufacturer Received11/05/2013
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: 10/11/2012 Patient Sequence Number: 1
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