MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

Model Number 302-20

Device Problems Extrusion (2934); Human-Device Interface Problem (2949)

Patient Problems Erosion (1750); Unspecified Infection (1930); Dysphasia (2195); Injury (2348)

Event Date 10/29/2014

Event Type  Injury  

Event Description

On 12/01/2014, it was reported that the patient had an injury at his lead site at the collarbone and a subsequent infection.The patient was working on his home and left his caulking removal tool at the top of the ladder and when he climbed back up the ladder his tool fell and struck him in the chest.The patient made an appointment with his physician, and during his appointment on (b)(6) 2014, the patient was put on antibiotics.He returned for follow-up one week later and was told it was getting moderately better.A week after that appointment ((b)(6) 2014), he was told it was improving but he was not doing as well as expected.The physician stated the infection had attached itself to the lead wires.On a 3rd visit a week later ((b)(6) 2014), the general chest infection had cleared up but remained on the lead wire.The patient was then referred to an infectious diseases doctor who recommended that the vns therapy system be removed.It was also reported that the patient¿s leads were fractured and the ¿wire is sticking out of the skin¿.The patient declined to be re-implanted as he had not had efficacy with vns.He stated that he knows the vns is no longer working because he no longer feels hoarseness in his throat or voice alteration and there was usually a ¿tickle on the vocal cord¿ during stimulation.Although surgery is likely, it has not occurred 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: 4334606
• MDR Text Key: 5140329
• Report Number: 1644487-2014-03356
• 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: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2006
• Device Model Number: 302-20
• Device Lot Number: 011003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2004
• 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): Other
• Patient Age: 70 YR