MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem Fall (1848)

Event Date 08/19/2016

Event Type  malfunction  

Event Description

It was reported the patient was seen in clinic on (b)(6) 2016 and it was found that the patient's vns had high impedance.The patient's device was programmed off once the high impedance was observed.The physician ordered chest x-rays and the patient was referred for surgery.It was later reported that the x-rays were reviewed by the physician and the "lead was compromised" and the patient was referred to the surgeon.It was noted that the mother stated the patient did have a fall and needs shoulder surgery, but it is unknown if this is when the lead got damaged.No known surgical interventions have occurred to date.

Event Description

It was later reported the patient underwent a full vns revision on (b)(6) 2016.The lead impedance was checked with the new device in place and was found to be within normal limits.Device return was requested; however, the device has not been received to date.

Event Description

It was noted the hospital where the vns was replaced discards explanted products and does not return to the manufacturer.

• 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: 5956114
• MDR Text Key: 55261330
• Report Number: 1644487-2016-02095
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2005
• Device Model Number: 302-20
• Device Lot Number: 8434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2003
• 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: 35 YR