MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

Model Number 302-20

Device Problems High impedance (1291); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 03/04/2015

Event Type  malfunction  

Event Description

It was reported that the patient was seen that day and high lead impedance >10,000 ohms was seen.She had her battery replaced on (b)(6) 2014.X-rays had already been taken but there was nothing clearly discernible from them.These will not be sent in for review.The physician is aware of the recommendation to disable the device but decided to leave the device on.The patient¿s mother did mention that the patient had been manipulating the device after her replacement surgery in (b)(6) 2014.The physician is going to schedule the patient for surgery to fix her vns.He will try re-inserting the pin first.If that doesn't resolve the issue he will revise the patient's lead.On (b)(6) 2015 the patient underwent a full revision.After the new generator was inserted, a systems diagnostic test was run twice with high lead impedance (>10,000 ohms) observed both times, so the lead was also replaced.The physician believes that the original lead coils were not on the nerve.The explanted devices are not retrievable for return.

• 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: 4653150
• MDR Text Key: 5603723
• Report Number: 1644487-2015-04356
• 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: 03/04/2015

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: 09/30/2004
• Device Model Number: 302-20
• Device Lot Number: 1150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/04/2015
• Initial Date FDA Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2002
• 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: 26 YR