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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 05/01/2015
Event Type  Injury  
Event Description

It was reported that the patient had picked at the neck incision site and pulled out the leads. Patient managed to pick open his neck incision and was seen on (b)(6) 2015. The physician was able to see some of suture underneath the and determined it best to explant the device as patient might end up pulling out a portion of the vns with a risk of infection. Patient underwent full explant on (b)(6) 2015. Additional information was received that the patient previously picked the chest incision site causing wound dehiscence. This is reported in manufacturer report # 1644487-2015-04803.

 
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Brand NameLEAD MODEL UNKNOWN
Type of DeviceLEAD
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 Key4803482
Report Number1644487-2015-04804
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/06/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/28/2015
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
Event Location Other
Date Manufacturer Received05/06/2015
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 TREATMENT DATA
Date Received: 05/28/2015 Patient Sequence Number: 1
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