MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

Device Problem Insufficient Information (3190)

Patient Problems Seizures (2063); Seroma (2069); No Code Available (3191)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.

Event Description

It was reported by the patient that approximately 9 months ago they woke up and saw that they had developed a blister on their collarbone and could visually see the "copper wrapped vagus nerve directly below it." by "copper wrapped vagus nerve", it was presumed that meant the lead product.The patient reported that, since this event, he had too many seizures.The patient indicated that the wire (presumably at the point of the blister) appeared visibly smaller than the rest of the wires.The patient reported that the electricity seemed to have problems going through the narrower passage and that the electricity did not reach its intended destination.No known surgical intervention has occurred to date.No further relevant 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: 8095658
• MDR Text Key: 128080837
• Report Number: 1644487-2018-02134
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/23/2018
• Device Model Number: 304-20
• Device Lot Number: 203187
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/01/2018
• Initial Date FDA Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2014
• 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: 61 YR