MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

Model Number 302-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Paralysis (1997); Dysphasia (2195)

Event Date 12/05/2013

Event Type  Injury  

Event Description

It was reported that the patient has been diagnosed with left vocal cord paralysis by an ent after full vns system replacement.Both the lead and generator were replaced.It was reported that the patient will be referred to speech re-training.It was reported that the patient has benefitted from vns therapy.It was reported that the patient experienced dysphonia upon return from surgery.The dysphonia was initially attributed to disorders resulting from intubation (laryngitis post intubation), but with continuing unrest, despite correct treatment, the situation has been reevaluated and paralysis of the recurrent laryngeal nerve was confirmed.It was reported that the device was not programmed on until (b)(6) 2013 which was after the dysphonia problems.No additional information has been received to date.

• 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: 3546950
• MDR Text Key: 3979035
• Report Number: 1644487-2014-00006
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2017
• Device Model Number: 302-20
• Device Lot Number: 3604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/05/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2013
• 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: 21 YR