MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Patient Problem/Medical Problem (2688)

Event Date 12/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient developed a post-surgical infection.The infection presented as red streaking down the patient's left arm, and she was treated with antibiotics.The symptoms of infection had reportedly resolved at that time.Subsequently, the patient visited the emergency room with the red streaking returning and accompanied by pain and swelling in the left arm.The physician ruled out deep-vein thrombosis, and concluded with a diagnosis of post-operative thrombophlebitis.No interventions for the thrombophlebitis have occurred.The patient was not admitted to the hospital.The notes received from the physician appear to indicate that the patient has her generator implanted in the left arm.A review of device history records showed that the generator was sterilized prior to distribution.No additional relevant information has been received to date.

Event Description

Follow up communication indicated that the patient's generator was actually implanted in her left armpit.Additionally, it was indicated that the patient was a regular smoker.This was the same location that her previous generator was located.No additional pertinent information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 5397383
• MDR Text Key: 37084076
• Report Number: 1644487-2016-00143
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2017
• Device Model Number: 106
• Device Lot Number: 203585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2015
• 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): Required Intervention
• Patient Age: 27 YR