MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problem Insufficient Information (3190)

Patient Problem Fibrosis (3167)

Event Date 09/06/2016

Event Type  Injury  

Event Description

It was reported through an implant card that patient underwent a full revision due to strong fibrosis and stimulation of the muscle.Company representative was present in the or.The plan was a lead replacement but after the connection of the new lead to the generator a "near end of service" flag was observed.They decided to replace the generator as well.Company representative indicated that the follow up physician has the patient in visit in (b)(6) 2016 for the last visit before the intervention took place.No product failure was reported or suspected.It was reported that no explanted devices are available for the return.

Event Description

Further follow up indicated that the surgeons saw the fibrosis on the mri, and so they decided to perform new lead implantation.It was reported that sometimes the patient felts the stimulation because the muscle twitched.This is more a physiological process by the patient.The available programming history data was reviewed, this review showed that the diagnostic test was recorded only on two dates: on (b)(6) 2012 the impedance value was 1864 ohms and on (b)(6) 2012, the lead impedance was 3473 ohms.Those values support the reported fibrosis.Further attempts, to obtain more information about this incident, were unsuccessful to date.

• Brand Name: LEAD MODEL 304
• 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: 5989722
• MDR Text Key: 55989624
• Report Number: 1644487-2016-02234
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2015
• Device Model Number: 304-20
• Device Lot Number: 3153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2011
• 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 Outcome(s): Required Intervention
• Patient Age: 51 YR