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

Model Number 102

Device Problem Reset Problem (3019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2015

Event Type  malfunction  

Event Description

It was reported that the patient's generator was reset to 0ma twice after the patient was sent home.It was reported that faulted diagnostics were not believed to be the cause of the change in settings.Attempts to obtain additional relevant information have been unsuccessful to date.

• 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: 4892367
• MDR Text Key: 6830505
• Report Number: 1644487-2015-05088
• 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
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 07/06/2015
• 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 Age: 43 YR