MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problem No Code Available (3191)

Event Date 10/06/2017

Event Type  Injury  

Event Description

It was reported that the patient was to have the vns device explanted.It was later found that the patient's device did not seem to be working for her and the generator kept flipping around in the patient's chest.The generator was explanted however the device has not been received by the manufacturer to date.

Event Description

Additional information was received that the patient self referred herself for explant of the device with complaints of the device moving.The migration was stated to not be bothersome for the patient.The explanted lead and generator were received by the manufacturer for product analysis.

Event Description

Product analysis was completed on the returned lead and generator.The lead was returned in one portion that included the connector pin but not the electrodes.There were set screw marks observed on the connector pin that indicate that proper contact existed at some point in time.Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portion.The generator analysis was completed and the device was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 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: 7062444
• MDR Text Key: 93028364
• Report Number: 1644487-2017-04870
• Device Sequence Number: 1
• Product Code: MUZ
• 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,Followup,Followup
• Report Date: 01/19/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/11/2008
• Device Model Number: 102
• Device Lot Number: 015030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/02/2017
• Initial Date FDA Received: 11/27/2017
• Supplement Dates Manufacturer Received: 12/07/2017; 01/04/2018
• Supplement Dates FDA Received: 01/02/2018; 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 51 YR