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

Model Number 106

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

Patient Problems Unspecified Infection (1930); Twiddlers Syndrome (2114)

Event Date 07/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that recently implanted vns patient had the vns system removed and not replaced.The patient has been admitted with an infection, which covers practically the whole of the generator site and the neck wound site.It was reported by the mother to the surgeon that the patient has been touching and picking the wound sites.Patient will probably have to stay in the hospital for a few days for intravenous antibiotics as the wound does not look pleasant, but the extent of the infection in unknown until the surgeon removes the generator.Additional information received that on the previous testing; the vns system was performing as intended.The device was turned off on (b)(6) 2016.The vns removal was performed in two surgeries dates.Generator removed on (b)(6) 2016 and further surgery to remove leads on (b)(6) 2016.It's believed that the neck wound became infected hence why the surgeon had to remove this.The cause of the infection is definitely due to the patient touching, manipulating and picking the generator wound site/neck wound site.

Event Description

The explanting facility discarded the explanted device; therefore, no analysis can be performed.

• 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: 6140638
• MDR Text Key: 61293316
• Report Number: 1644487-2016-02766
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/09/2016

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
• Device Expiration Date: 04/13/2018
• Device Model Number: 106
• Device Lot Number: 203814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/09/2016
• Initial Date FDA Received: 12/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2016
• 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: 12 YR