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

Device Problems Improper or Incorrect Procedure or Method (2017); Material Protrusion/Extrusion (2979)

Patient Problems Failure to Anastomose (1028); Abscess (1690); Cyst(s) (1800); Rupture (2208)

Event Date 11/13/2014

Event Type  Injury  

Event Description

It was reported that the vns patient had developed a cyst/abscess at her neck incision site that ruptured causing the incision site to open.The lead was extruding from the patient¿s incision site and there were concerns that the patient may injure herself or damage the device.Surgical dressing was used to cover the wound but the patient kept picking it off.No known surgical interventions have occurred to date.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Additional information was received stating that the vns patient underwent surgery on (b)(6) 2014 for wound debridement and to reclose the incision site.The patient continued to manipulate the incision site so the patient underwent surgery on (b)(6) 2014 to explant her device due to infection.

Event Description

Further information was received indicating that the patient had undergone a battery replacement on (b)(6) 2013.

• Brand Name: LEAD MODEL UNKNOWN
• 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: 4325307
• MDR Text Key: 19315922
• Report Number: 1644487-2014-03284
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/02/2015
• Initial Date FDA Received: 12/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 20 YR