MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problem Unspecified Infection (1930)

Event Date 08/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the physician's office that the patient was admitted to the hospital due to infection.The patient was going to be replaced; however, the site did not have a replacement generator and needed a company representative to provide one for the replacement.A company representative later confirmed he attended the replacement surgery on (b)(6) 2016.He confirmed the patient's generator was replaced due to infection and the new generator remained programmed off.Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution.Attempts for additional relevant information have been unsuccessful to date.

Event Description

The explanted generator was received by the manufacturer for analysis.Product analysis is expected, but has not been completed to date.

Event Description

Product analysis (pa) for the returned generator was completed.While the reported infection is beyond the scope of the activities performed within the pa lab, the potential contributing factors have been considered and evaluated and none were found to exist in the reported situation.The diagnostics for the generator were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed the generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the generator.

Event Description

It was later reported by the physician that the infection was first observed within the clinic on (b)(6) 2016.Due to this information, additional follow up was performed at which point it was explained that the patient had a subsequent infection and that the original infection was first observed on (b)(6) 2016.It was noted the family had called the physician's office on (b)(6) 2016 with a report of swelling, the patient went to the ed (emergency department) on (b)(6) 2016, and the generator device was replaced on (b)(6) 2016.During the replacement surgery on (b)(6) 2016, the chest wall was washed out and the patient was placed on a normal regimen of iv antibiotics.It was noted the believed cause of the infection was due to the placement of the device in the axillary region, as opposed to the chest, and the patient is in a wheelchair.It is felt that the sweat is a contributing factor in the wound getting infected.The information regarding the second infection has been reported in mfr.Report 1644487-2016-02467.

• Brand Name: PULSE GEN MODEL 105
• 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: 5942349
• MDR Text Key: 54401782
• Report Number: 1644487-2016-02046
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/05/2017
• Device Model Number: 105
• Device Lot Number: 4264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2015
• 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: 17 YR