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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL UNKNOWN

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CYBERONICS, INC. LEAD MODEL UNKNOWN Back to Search Results
Event Date 01/01/2004
Event Type  Malfunction  
Event Description

It was reported in an article that during initial vns placement, a preliminary lead test showed hight lead impedance. Corrective measures were taken, including repositioning of the electrodes, and a standard lead test was performed. Good faith attempts to obtain additional information have been unsuccessful to date.

 
Manufacturer Narrative

"complete heart block with ventricular asystole during left vagus nerve stimulation for epilepsy. " epilepsy & behavior 5 (2004) 768-771. Conclusions: device failure is suspected.

 
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Brand NameLEAD MODEL UNKNOWN
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
michael carroll
100 cyberonics blvd.
suite 600
houston , TX 77058
2812287200
MDR Report Key1123809
Report Number1644487-2008-01922
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/12/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/15/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/12/2008
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

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