MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

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.

• Brand Name: LEAD MODEL 304
• 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 Key: 5542841
• MDR Text Key: 42507715
• Report Number: 1644487-2016-00688
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2016

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: Lay User/Patient
• Device Expiration Date: 07/31/2015
• Device Model Number: 304-20
• Device Lot Number: 3049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/07/2016
• Initial Date FDA Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 15 YR