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

Model Number 102R

Device Problems Loss of Power (1475); Device Operates Differently Than Expected (2913)

Patient Problem Arrhythmia (1721)

Event Date 03/01/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 it was reported that the patient was hospitalized and that the patient began having an arrhythmia.The cardiologist thought that the vns was causing it.This was described as "long pulses." they used the magnet to shut off the device and reported that the arrhythmias went away.The neurologist requested that the device be disabled.The physician wanted to wait on performing diagnostics, that he would perform that later.Good faith attempts for further information from the physician were unsuccessful.

• Brand Name: PULSE GEN MODEL 102R
• 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: 4647805
• MDR Text Key: 5600152
• Report Number: 1644487-2015-04329
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2008
• Device Model Number: 102R
• Device Lot Number: 015790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2006
• 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): Hospitalization; Required Intervention
• Patient Age: 24 YR