MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101; GENERATOR

Model Number 101

Event Date 09/22/2014

Event Type  Injury  

Event Description

Initially, it was reported that the patient complained of pain at the neck area.It was later reported that the patient was at the hospital.It was reported that the patient had gone to the hospital for complaints of chest pain at the generator site.The device was programmed off.It was reported that the generator was at end of service.The patient is currently in the psychiatric hospital and no further action is being taken at this time.No additional relevant information has been received to date.

Event Description

Additional information was received stating that the vns patient had severe psychological issues.

• Brand Name: PULSE GEN MODEL 101
• 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: 4175290
• MDR Text Key: 16303532
• Report Number: 1644487-2014-02708
• 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: 09/22/2014

1 Device 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: 08/31/2001
• Device Model Number: 101
• Device Lot Number: 38527C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 10/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2000
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial