MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 304

Model Number 304-20

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Weight Changes (2607)

Event Date 04/15/2014

Event Type  Injury  

Event Description

It was reported that the vns patient was scheduled for surgery to replace his generator due to end of service on (b)(6) 2014.During the procedure, it was determined that the patient¿s device was not at end of service so the generator was not replaced at the time.The surgeon noted during the procedure that the patient¿s lead was extruding from his neck.Intervention was required to prevent any adverse events as the lead was exposed.The surgeon buried the lead medially and secured it with a suture.Further follow-up revealed that the patient may have been manipulating the lead but the patient denied any manipulation or trauma had occurred.The patient did not have any physiological changes that may have caused or contributed to the reported event.It was noted that the patient had lost 10 kg since his last revision surgery in 2012.

• 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: 3803231
• MDR Text Key: 4526220
• Report Number: 1644487-2014-01234
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/09/2015
• Device Model Number: 304-20
• Device Lot Number: 3131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/15/2014
• Initial Date FDA Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2011
• 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: 36 YR