MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

Model Number 302-20

Device Problem Human-Device Interface Problem (2949)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 06/29/2014

Event Type  Injury  

Event Description

It was reported that the patient was referred for generator and lead replacement due to shooting pain up to the patient's ear with device stimulation.It was reported that the generator would be replaced prophylactically due to the amount of time implanted.An implant card was received indicating that the patient underwent generator and lead replacement due to prophylactic reasons.The explanting facility discarded the explanted devices; therefore, product analysis cannot be performed.The physician reported that the patient was hit in the neck with something and the pain with device stimulation began.It was reported that device diagnostics were within normal limits prior to explant.The physician believed it would be best to have the entire vns system replaced due to the pain and time the generator had been implanted.

• 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: 4120189
• MDR Text Key: 16302434
• Report Number: 1644487-2014-02487
• 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: Physician
• Type of Report: Initial
• Report Date: 08/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2010
• Device Model Number: 302-20
• Device Lot Number: 200560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2007
• 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 Outcome(s): Required Intervention
• Patient Age: 55 YR