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

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported via clinic notes that a patient had an abdominal infection with a past generator replacement surgery.It is unknown which of the patient's surgeries the infection occurred after.The surgeon reported that the abdominal infection was unrelated to the vns implant site.The patient remained in the hospital after surgery for the infection to be treated.No additional relevant information has been provided to date.

Event Description

It was reported that the physician did not know more about the abdominal infection mentioned in the clinic notes as she did not have a prior history with the patient.The patient reportedly had a previous gallbladder surgery at another surgical facility, but the date and outcomes of the surgery were unknown to the physician.The physician did not state whether the gallbladder surgery was or was not related to the abdominal infection.No additional information has been provided.

• Brand Name: PULSE GEN MODEL UNKNOWN
• 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: 6415443
• MDR Text Key: 70297420
• Report Number: 1644487-2017-03425
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2017

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/20/2017
• Initial Date FDA Received: 03/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2017
• 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): Hospitalization; Required Intervention