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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL UNKNOWN
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CYBERONICS - HOUSTON LEAD MODEL UNKNOWN Back to Search Results
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem Pain (1994)
Event Date 02/01/2015
Event Type  Injury  
Event Description
It was reported that vns patient complained of a lump in his neck, which was investigated in (b)(6) 2015, with patient being referred to the implanting surgeon.It was reported that the lump came up, was painful and was suspected to be caused by the tie-downs from the lead which maybe protruding.It was reported that x-rays were taken but the results are not available.Attempts for additional relevant information have been unsuccessful to date.
 
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Brand Name
LEAD MODEL UNKNOWN
Type of Device
LEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key6043179
MDR Text Key57925598
Report Number1644487-2016-02411
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2016
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 Received09/27/2016
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
Patient Outcome(s) Required Intervention;
Patient Age12 YR
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