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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
Device Problem High impedance (1291)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/23/2012
Event Type  malfunction  
Event Description
During review of programming and diagnostic history, it was observed that the vns patient¿s device was tested on (b)(6) 2012 and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms).The high impedance condition resolved the following day.No patient adverse events were reported.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
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Brand Name
LEAD MODEL UNKNOWN
Type of Device
LEAD
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
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 Key4519439
MDR Text Key5405130
Report Number1644487-2015-03852
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2015
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? No
Event Location Other
Date Manufacturer Received01/21/2015
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 Sequence Number1
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