MAUDE Adverse Event Report: CYBERONICS LEAD MODEL UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Paresis (1998); Seizures (2063)

Event Date 06/01/2014

Event Type  Injury  

Event Description

Data was collected retrospectively from epilepsy patients with vns aspiresr implanted between june 2014 and june 2017 by a single surgeon in order to compare the efficacy of the aspiresr to preceding vns battery models for battery replacements and new implants.This article reports several events, including vocal cord paresis and suspected lead migration, and high impedance.The product problem event of high impedance attributed to the lead in the article is captured in mfr.Report #1644487-2018-00974.This report captures the adverse events in the article that are attributed to the lead.It was reported in the study that there were four cases of transient vocal cord paresis.All cases were resolved within 4-6 months.One case of lead migration was suspected after a severe convulsive seizure soon after implant insertion and revision surgery was performed.No further relevant information has been received to date.

• Brand Name: LEAD MODEL UNKNOWN
• 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: 7574919
• MDR Text Key: 110272166
• Report Number: 1644487-2018-00971
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• 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
• Date Manufacturer Received: 05/14/2018
• 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; Required Intervention