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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302
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CYBERONICS - HOUSTON LEAD MODEL 302 Back to Search Results
Model Number 302-30
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/19/2015
Event Type  malfunction  
Event Description
During planned generator replacement, the surgeon observed a defect in the lead insulation and fluid was found within the insulation.As a result, the lead was also replaced.No patient adverse events were reported.The explanted devices were discarded by the facility, and no analysis can be performed.
 
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Brand Name
LEAD MODEL 302
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 Key5021420
MDR Text Key24670999
Report Number1644487-2015-05565
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Report Date 08/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/30/2009
Device Model Number302-30
Device Lot Number1609
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Date Manufacturer Received08/03/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2006
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 Age33 YR
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