MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

Model Number 302-20

Device Problems Crack (1135); Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)

Patient Problem No Code Available (3191)

Event Date 11/20/2014

Event Type  malfunction  

Event Description

It was reported that the patient was undergoing a generator replacement on (b)(6) 2014 due to battery depletion and unable to interrogate due to end of service.During surgery the surgeon noted that the patient¿s lead was twisted and cracked but system diagnostics were within normal limits.The surgeon didn¿t have a back-up lead and wasn¿t able to perform a lead revision.The neurologist was notified in order to closely monitor the patient going forward.The surgeon believed the twisting and cracking of the lead was due to patient manipulation.The patient was not referred for a revision; the neurologist will just monitor her.The explanted generator was returned for product analysis.An open can measurement of the battery voltage determined that the battery was depleted.Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition.The reported ¿failure to program¿ allegation was duplicated in the pa lab and determined to be the result of normal battery depletion.No abnormal performance or any other type of adverse condition was found with the generator.

Manufacturer Narrative

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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 Key: 4324795
• MDR Text Key: 19314931
• Report Number: 1644487-2014-03272
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/20/2014

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: 08/31/2004
• Device Model Number: 302-20
• Device Lot Number: 3900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2002
• 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: 43 YR