MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

Device Problems Break (1069); Material Frayed (1262); Device Damaged by Another Device (2915)

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

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that during a vns repositioning surgery for placement of a gastrostomy tube unrelated to vns, the surgeon pulled on the lead and it appeared to have broken while he tugged on it from its location at the upper incision.An implant card was also received indicating the lead was "fissured" during surgery when the lead was pulled back for repositioning.The generator was previously in the abdomen due to the patient's small size.The physician wanted to salvage the lead and replacement was not intended.They needed to re-tunnel for the lead so both incision sites were opened.The physician tugged the lead back, towards the neck.It was reported that the lead had frayed and broken near the lead pin and occurred while the physician was pulling on it very hard by hand.No surgical instruments were used on the lead.Diagnostics after the break were high.It was noted that the case was very difficult based on the patient铠size and complication due to the gastrostomy tube.It was reported that diagnostics were reportedly within normal limits prior to surgery.The generator was replaced as the battery was reported to be at near-end-of-service.The lead was discarded at the end of the procedure.The explanted generator has not been received to-date.No additional information has been received to-date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5190183
• MDR Text Key: 30421207
• Report Number: 1644487-2015-06238
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Model Number: 304-20
• Device Lot Number: 202593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2013
• 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 Age: 3 YR