MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL UNK; LEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Discomfort (2330); No Code Available (3191)

Event Date 01/02/2017

Event Type  Injury  

Event Description

An article was received that reported multiple adverse events and a malfunction.The current report captures the adverse events associated with the lead.Mfr.Report # 1644487-2017-04155 captures the malfunction reported by the article.Mfr.Report # 1644487-2017-04153 captures adverse events associated with the generator.There was one intraoperative event associated with the lead.This patient experienced mild oozing from the jugular vein that was controlled by bipolar cautery.One patient had a prominent electrode in his neck which presented as pain and discomfort within a week post operatively.Two other patient's also had pain due to prominent electrodes, but these were associated with trauma to the vns area.These three patient's neck wounds were revised and the electrodes repositioned.The article later describes these electrodes as being "dislodged." no further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL UNK
• 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: 6723266
• MDR Text Key: 80379952
• Report Number: 1644487-2017-04154
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: JO
• 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: 07/18/2017

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: 06/19/2017
• Initial Date FDA Received: 07/18/2017
• 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): Required Intervention