MAUDE Adverse Event Report: CYBERONICS LEAD MODEL 304

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

An article titled "complications and safety of vagus nerve stimulation ¿ 25 years¿ experience at a single center¿ was published and the abstract was reviewed, which included adverse events involving vns patients.In many procedures performed between 1990 and 2014, patients suffered from complications related to vns surgery.The article reports of thirteen lead malfunctions in 12 patients (no children).Lead exploration to try to salvage the lead was required in 5 cases, 1 was successful and the remaining resulted in replacements.In 2 adult patients, an immediate postoperative lead disconnection was suspected, resulting in an early surgical reconnection.This was probably due to unsuccessful connection between the lead and stimulator during primary surgery.It is unclear if the surgeon performed a proper lead test in these cases.Not all lead fractures were visible on radiography, and the lead failures were mainly detected by diminished function, e.G., increased seizure frequency and increased impedance measurement leading to revision or replacement of the lead.Only a few were detected on radiography, and the etiology of high impedance is not entirely clear.Some have described lead failure in the absence of visible fractures as ¿microlesions¿ within the lead cable others have presented significant scar tissue around the as a possible cause of high impedance.We report 13 cases (3.0%) of lead malfunction, of which no children were involved.Previous studies report 0.5% to 20.8%.The present reports of patient ((b)(6) at first implant) had a high lead impedance (lead failure or significant scar tissue) which was detected by diminished function (increased seizure frequency/increased impedance measurement).The patient had a full revision surgery in 1 session after 3.4 years.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS; 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: 5694084
• MDR Text Key: 47721236
• Report Number: 1644487-2016-01190
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/04/2016
• 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