MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 300

Model Number 300-30

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that high impedance was observed on vns patient's system.It was reported that the patient was to undergo generator replacement surgery, when high impedance was observed.In or, the patient's vns system was tested upon connection of the new generator to the existing lead and system diagnostics returned impedance results within normal limits.The physician decided then to close the patient and wait.Further information indicated that impedance tests were run the day after the surgery and high impedance was found again.No patient adverse events were reported.It was reported that lead revision is planned.No known surgical interventions have been performed to date.

Event Description

Additional information was received through an implant card indicating that the patient underwent full revision surgery on (b)(6) 2016.The explanted devices are not available for the return to the manufacturer for the analysis.It was reported that the generator was replaced due to the incompatibility with the new implanted lead model.It was reported that the patient is doing well after the replacement surgery.

Event Description

New information was received that the patient was implanted on the right vagus nerve.The patient is now having paralysis of the vocal cord.The vocal cord paralysis is reported in mfr.Report # 1644487-2016-02082.

• Brand Name: LEAD MODEL 300
• 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: 5952365
• MDR Text Key: 55171319
• Report Number: 1644487-2016-02082
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2002
• Device Model Number: 300-30
• Device Lot Number: 1202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2000
• 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: 56 YR