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

Device Problem Insufficient Information (3190)

Patient Problem Arrhythmia (1721)

Event Date 07/22/2014

Event Type  Injury  

Event Description

It was reported that the vns patient had arrhythmia and was to undergo tee-guided cardioversion.It is unknown whether the patient¿s arrhythmia was related to vns.Attempts for additional relevant information have been unsuccessful to date.

Event Description

The physician reported that the patient does not have the arrythmia due to vns.The physician indicated that the routine cardioversion is for an unrelated condition.

• Brand Name: PULSE GEN MODEL UNK
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4012875
• MDR Text Key: 4689117
• Report Number: 1644487-2014-02036
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2014
• 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: 08/18/2014
• 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