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CYBERONICS - HOUSTON LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2016
Event Type  Malfunction  
Event Description

During a prophylactic generator replacement (ifi = yes) on (b)(6) 2016, the surgeon accidentally cut the lead and had to perform lead revision. The explanted generator and lead were received. An analysis was performed on the returned lead portions. The reported allegations of lead fracture due to surgeon accidentally cutting the lead was confirmed based on the condition of the returned lead portions. During the visual analysis of the returned lead, abraded openings were observed on the connector pin and connector ring inner silicone tubes. Pitting was observed on the connector ring quadfilar coil surface, in this area. Analysis confirmed opening of both inner tubing sections in adjacent areas, exposing conductive quadfilar coils and resulting in coil pitting and a potential short-circuit condition. With the exception of the slice marks, puncture marks and abraded inner tubing openings, the condition of the returned lead portions is consistent with those that typically exist following an explant procedure. The abraded openings of both inner tubes is suspected to have occurred during the implant life and prior to explant surgery. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings, there is no evidence to suggest discontinuities in the returned portions of the device which may have contributed to the stated allegations of high impedance/lead fractures. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 914 volts, shows an ifi=no condition. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. There were no performance or any other type of adverse conditions found with the pulse generator.

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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston, TX 77058
MDR Report Key5542841
MDR Text Key42507715
Report Number1644487-2016-00688
Device Sequence Number1
Product Code LYJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 03/07/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/01/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2015
Device MODEL Number304-20
Device LOT Number3049
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/18/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/07/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/07/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial