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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 Problems High impedance (1291); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/19/2014
Event Type  malfunction  
Event Description
It was reported that during initial vns implant surgery on (b)(6) 2014, the patient¿s lead electrodes were observed to be not in contact with the patient¿s vagus nerve.As result, diagnostic results showed high impedance.It was noted that the patient¿s vagus nerve was very thin.No known surgical interventions for the reported high impedance and electrode placement have occurred to date.
 
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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 Key4096581
MDR Text Key18570381
Report Number1644487-2014-02367
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 08/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 08/19/2014
Initial Date FDA Received09/17/2014
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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